Device Adverse Events

  • 0 ::
      • Manufacturer_contact_t_name :
        • Manufacturer_g1_name :
          • Number_patients_in_event :
            • Manufacturer_g1_city :
              • Event_type : Injury
                • Manufacturer_city :
                  • Report_number : 364
                    • Patient ::
                        • 0 ::
                            • Patient_sequence_number : 1
                              • Sequence_number_treatment ::
                                  • 0 :
                                • Date_received : 19911224
                                  • Sequence_number_outcome ::
                                      • 0 : 1. R
                                • 1 ::
                                    • Patient_sequence_number : 1
                                      • Sequence_number_treatment ::
                                          • 0 :
                                        • Date_received : 19911224
                                          • Sequence_number_outcome ::
                                              • 0 : 1. R
                                    • Product_problem_flag : N
                                      • Date_report_to_fda : 19911204
                                        • Manufacturer_country :
                                          • Manufacturer_g1_address_2 :
                                            • Manufacturer_g1_address_1 :
                                              • Distributor_zip_code :
                                                • Report_date : 19911204
                                                  • Date_report_to_manufacturer : 19911127
                                                    • Manufacturer_contact_city :
                                                      • Distributor_address_2 :
                                                        • Date_facility_aware : 19911126
                                                          • Single_use_flag :
                                                            • Manufacturer_contact_plocal :
                                                              • Event_location : HOSPITAL
                                                                • Manufacturer_contact_address_2 :
                                                                  • Manufacturer_g1_state :
                                                                    • Manufacturer_contact_phone_number :
                                                                      • Manufacturer_name :
                                                                        • Distributor_address_1 :
                                                                          • Date_of_event : 19911126
                                                                            • Manufacturer_contact_extension :
                                                                              • Report_source_code : User Facility report
                                                                                • Distributor_state :
                                                                                  • Remedial_action ::
                                                                                      • 0 :
                                                                                    • Number_devices_in_event :
                                                                                      • Manufacturer_contact_zip_ext :
                                                                                        • Date_received : 19911224
                                                                                          • Manufacturer_g1_zip_code_ext :
                                                                                            • Mdr_text ::
                                                                                                • 0 ::
                                                                                                    • Patient_sequence_number : 1
                                                                                                      • Text : END PORTION OF UMBRELLA CATHETER SEPERATED AND LODGED IN RIGHT ATRIUM DURING CATH. PROCEDURE. PATIENT FELT NO DISCOMFORT, BUT WAS TRANSFERED TO OTHER MEDICAL FACILITY FOR EMERGENCY SURGERY TO REMOVE CATHETER TIPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.
                                                                                                        • Text_type_code : Description of Event or Problem
                                                                                                          • Mdr_text_key : 18609932
                                                                                                    • Reprocessed_and_reused_flag :
                                                                                                      • Type_of_report ::
                                                                                                          • 0 : Initial submission
                                                                                                        • Manufacturer_zip_code_ext :
                                                                                                          • Manufacturer_contact_country :
                                                                                                            • Health_professional :
                                                                                                              • Manufacturer_contact_area_code :
                                                                                                                • Event_key :
                                                                                                                  • Manufacturer_g1_zip_code :
                                                                                                                    • Manufacturer_g1_country :
                                                                                                                      • Manufacturer_contact_pcity :
                                                                                                                        • Mdr_report_key : 364
                                                                                                                          • Distributor_city :
                                                                                                                            • Date_report : 19911204
                                                                                                                              • Manufacturer_zip_code :
                                                                                                                                • Manufacturer_contact_l_name :
                                                                                                                                  • Manufacturer_g1_postal_code :
                                                                                                                                    • Previous_use_code :
                                                                                                                                      • Manufacturer_contact_f_name :
                                                                                                                                        • Manufacturer_address_1 :
                                                                                                                                          • Manufacturer_contact_address_1 :
                                                                                                                                            • Manufacturer_contact_state :
                                                                                                                                              • Manufacturer_address_2 :
                                                                                                                                                • Manufacturer_state :
                                                                                                                                                  • Distributor_name :
                                                                                                                                                    • Reporter_occupation_code :
                                                                                                                                                      • Manufacturer_contact_exchange :
                                                                                                                                                        • Source_type ::
                                                                                                                                                            • 0 :
                                                                                                                                                          • Device ::
                                                                                                                                                              • 0 ::
                                                                                                                                                                  • Lot_number : UNKNOWN
                                                                                                                                                                    • Manufacturer_d_country :
                                                                                                                                                                      • Manufacturer_d_zip_code_ext :
                                                                                                                                                                        • Manufacturer_d_postal_code :
                                                                                                                                                                          • Device_event_key : 362
                                                                                                                                                                            • Baseline_510_k__exempt_flag :
                                                                                                                                                                              • Device_operator : OTHER HEALTH CARE PROFESSIONAL
                                                                                                                                                                                • Generic_name : VENA CAVA UMBRELLA FILTER
                                                                                                                                                                                  • Openfda ::
                                                                                                                                                                                      • Regulation_number :
                                                                                                                                                                                        • Medical_specialty_description : Unknown
                                                                                                                                                                                          • Device_class : 3
                                                                                                                                                                                            • Device_name : Occluder, Balloon, Vena-Cava
                                                                                                                                                                                          • Model_number : UNKNOWN
                                                                                                                                                                                            • Date_received : 19911224
                                                                                                                                                                                              • Device_evaluated_by_manufacturer :
                                                                                                                                                                                                • Manufacturer_d_zip_code :
                                                                                                                                                                                                  • Baseline_510_k__flag :
                                                                                                                                                                                                    • Device_sequence_number : 1
                                                                                                                                                                                                      • Device_age_text :
                                                                                                                                                                                                        • Brand_name :
                                                                                                                                                                                                          • Baseline_510_k__number :
                                                                                                                                                                                                            • Manufacturer_d_state :
                                                                                                                                                                                                              • Other_id_number : UNKNOWN
                                                                                                                                                                                                                • Implant_flag : Y
                                                                                                                                                                                                                  • Manufacturer_d_address_2 :
                                                                                                                                                                                                                    • Catalog_number : UNKNOWN
                                                                                                                                                                                                                      • Manufacturer_d_address_1 :
                                                                                                                                                                                                                        • Manufacturer_d_city :
                                                                                                                                                                                                                          • Manufacturer_d_name : MEDITECH
                                                                                                                                                                                                                            • Device_availability : No
                                                                                                                                                                                                                              • Date_removed_flag :
                                                                                                                                                                                                                                • Device_report_product_code : LWT
                                                                                                                                                                                                                          • Report_to_manufacturer :
                                                                                                                                                                                                                            • Manufacturer_contact_zip_code :
                                                                                                                                                                                                                              • Manufacturer_link_flag : N
                                                                                                                                                                                                                                • Adverse_event_flag : Y
                                                                                                                                                                                                                                  • Report_to_fda : Y
                                                                                                                                                                                                                                    • Removal_correction_number :
                                                                                                                                                                                                                                      • Manufacturer_contact_postal_code :
                                                                                                                                                                                                                                        • Distributor_zip_code_ext :
                                                                                                                                                                                                                                          • Initial_report_to_fda :
                                                                                                                                                                                                                                            • Manufacturer_postal_code :
                                                                                                                                                                                                                                              • Manufacturer_contact_pcountry :

Device Adverse Events

  • 1 ::
      • Manufacturer_contact_t_name :
        • Manufacturer_g1_name :
          • Number_patients_in_event :
            • Manufacturer_g1_city :
              • Event_type : Death
                • Manufacturer_city :
                  • Report_number : 131
                    • Patient ::
                        • 0 ::
                            • Patient_sequence_number : 1
                              • Sequence_number_treatment ::
                                  • 0 :
                                • Date_received : 19911231
                                  • Sequence_number_outcome ::
                                      • 0 : 1. D
                                • 1 ::
                                    • Patient_sequence_number : 1
                                      • Sequence_number_treatment ::
                                          • 0 :
                                        • Date_received : 19911231
                                          • Sequence_number_outcome ::
                                              • 0 : 1. D
                                    • Product_problem_flag : N
                                      • Date_report_to_fda : 19911223
                                        • Manufacturer_country :
                                          • Manufacturer_g1_address_2 :
                                            • Manufacturer_g1_address_1 :
                                              • Distributor_zip_code :
                                                • Report_date : 19911223
                                                  • Date_report_to_manufacturer : 19911216
                                                    • Manufacturer_contact_city :
                                                      • Distributor_address_2 :
                                                        • Date_facility_aware : 19911214
                                                          • Single_use_flag :
                                                            • Manufacturer_contact_plocal :
                                                              • Event_location : HOSPITAL
                                                                • Manufacturer_contact_address_2 :
                                                                  • Manufacturer_g1_state :
                                                                    • Manufacturer_contact_phone_number :
                                                                      • Manufacturer_name :
                                                                        • Distributor_address_1 :
                                                                          • Date_of_event : 19911214
                                                                            • Manufacturer_contact_extension :
                                                                              • Report_source_code : User Facility report
                                                                                • Distributor_state :
                                                                                  • Remedial_action ::
                                                                                      • 0 :
                                                                                    • Number_devices_in_event :
                                                                                      • Manufacturer_contact_zip_ext :
                                                                                        • Date_received : 19911231
                                                                                          • Manufacturer_g1_zip_code_ext :
                                                                                            • Mdr_text ::
                                                                                                • 0 ::
                                                                                                    • Patient_sequence_number : 1
                                                                                                      • Text : A PATIENT WAS BEING MONITORED WITH NELCOR MODEL N-200 PULSE OXIMETER OPERATING FROM AC LINE. AT APPROX. 12:05 A.M. ON 12/14/91, A NURSE ENTERED THE ROOM AND FOUND THE PATIENT TO BE NON-RESPONSIVE. SHE NOTED THAT THE PULSE OXIMETER WAS READING ZERO AND DOES NOT BELIEVE THAT THE UNIT WAS ALARMING AT THE TIME SHE ENTERED THE ROOM. VIGOROUS RESUSCITATIVE EFFORTS WERE UNDERTAKEN AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL ICU WHERE SHE EXPIRED ON 12/19/91. THE OXIMETER WAS IMMEDIATELY SECURED AND EVALUATED BY RESPIRATORY THERAPY AND MEDICAL ENGINEERING. THE OXIMETER DEMONSTRATED PROPER FUNCTIONING IN ALL TESTING MODES. ALTHOUGH THE INSPECTION REVEALED A CRACKED EXTERNAL CASE AND LOW BATTERY LIFE, THESE CONDITIONS HAVE PROVEN TO HAVE HAD NO EFFECT ON THE PERFORMANCE OF THE UNIT UNDER THE CIRCUMSTANCES AT THE TIME OF THE EVENT. THE UNIT PROVIDES ACCURATE OXYGEN SATURATION/PULSE RATE INDICATIONS AND APPROPRIATE ALARMS FOR THOSE PARAMETERS WHEN PREDETERMINATION LIMITS ARE EXCEEDEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MECHANICAL PROBLEM, NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
                                                                                                        • Text_type_code : Description of Event or Problem
                                                                                                          • Mdr_text_key : 112
                                                                                                    • Reprocessed_and_reused_flag :
                                                                                                      • Type_of_report ::
                                                                                                          • 0 : Initial submission
                                                                                                        • Manufacturer_zip_code_ext :
                                                                                                          • Manufacturer_contact_country :
                                                                                                            • Health_professional :
                                                                                                              • Manufacturer_contact_area_code :
                                                                                                                • Event_key :
                                                                                                                  • Manufacturer_g1_zip_code :
                                                                                                                    • Manufacturer_g1_country :
                                                                                                                      • Manufacturer_contact_pcity :
                                                                                                                        • Mdr_report_key : 131
                                                                                                                          • Distributor_city :
                                                                                                                            • Date_report : 19911223
                                                                                                                              • Manufacturer_zip_code :
                                                                                                                                • Manufacturer_contact_l_name :
                                                                                                                                  • Manufacturer_g1_postal_code :
                                                                                                                                    • Previous_use_code :
                                                                                                                                      • Manufacturer_contact_f_name :
                                                                                                                                        • Manufacturer_address_1 :
                                                                                                                                          • Manufacturer_contact_address_1 :
                                                                                                                                            • Manufacturer_contact_state :
                                                                                                                                              • Manufacturer_address_2 :
                                                                                                                                                • Manufacturer_state :
                                                                                                                                                  • Distributor_name :
                                                                                                                                                    • Reporter_occupation_code :
                                                                                                                                                      • Manufacturer_contact_exchange :
                                                                                                                                                        • Source_type ::
                                                                                                                                                            • 0 :
                                                                                                                                                          • Device ::
                                                                                                                                                              • 0 ::
                                                                                                                                                                  • Lot_number :
                                                                                                                                                                    • Manufacturer_d_country :
                                                                                                                                                                      • Manufacturer_d_zip_code_ext :
                                                                                                                                                                        • Manufacturer_d_postal_code :
                                                                                                                                                                          • Device_event_key : 129
                                                                                                                                                                            • Baseline_510_k__exempt_flag :
                                                                                                                                                                              • Device_operator : OTHER
                                                                                                                                                                                • Generic_name : PULSE OXIMETER
                                                                                                                                                                                  • Openfda ::
                                                                                                                                                                                      • Regulation_number : 870.2700
                                                                                                                                                                                        • Medical_specialty_description : Cardiovascular
                                                                                                                                                                                          • Device_class : 2
                                                                                                                                                                                            • Device_name : Oximeter
                                                                                                                                                                                          • Model_number : N-200
                                                                                                                                                                                            • Date_received : 19911231
                                                                                                                                                                                              • Device_evaluated_by_manufacturer :
                                                                                                                                                                                                • Manufacturer_d_zip_code :
                                                                                                                                                                                                  • Baseline_510_k__flag :
                                                                                                                                                                                                    • Device_sequence_number : 1
                                                                                                                                                                                                      • Device_age_text : 01-SEP-90
                                                                                                                                                                                                        • Brand_name : NELLCOR
                                                                                                                                                                                                          • Baseline_510_k__number :
                                                                                                                                                                                                            • Manufacturer_d_state :
                                                                                                                                                                                                              • Other_id_number : CN:12927
                                                                                                                                                                                                                • Implant_flag : N
                                                                                                                                                                                                                  • Manufacturer_d_address_2 :
                                                                                                                                                                                                                    • Catalog_number :
                                                                                                                                                                                                                      • Manufacturer_d_address_1 :
                                                                                                                                                                                                                        • Manufacturer_d_city :
                                                                                                                                                                                                                          • Manufacturer_d_name : NELLCOR
                                                                                                                                                                                                                            • Device_availability : Yes
                                                                                                                                                                                                                              • Date_removed_flag :
                                                                                                                                                                                                                                • Device_report_product_code : DQA
                                                                                                                                                                                                                          • Report_to_manufacturer :
                                                                                                                                                                                                                            • Manufacturer_contact_zip_code :
                                                                                                                                                                                                                              • Manufacturer_link_flag : N
                                                                                                                                                                                                                                • Adverse_event_flag : Y
                                                                                                                                                                                                                                  • Report_to_fda : Y
                                                                                                                                                                                                                                    • Removal_correction_number :
                                                                                                                                                                                                                                      • Manufacturer_contact_postal_code :
                                                                                                                                                                                                                                        • Distributor_zip_code_ext :
                                                                                                                                                                                                                                          • Initial_report_to_fda :
                                                                                                                                                                                                                                            • Manufacturer_postal_code :
                                                                                                                                                                                                                                              • Manufacturer_contact_pcountry :

Device Adverse Events

  • 2 ::
      • Manufacturer_contact_t_name :
        • Manufacturer_g1_name :
          • Number_patients_in_event :
            • Manufacturer_g1_city :
              • Event_type : Malfunction
                • Manufacturer_city :
                  • Report_number : 186
                    • Patient ::
                        • 0 ::
                            • Patient_sequence_number : 1
                              • Sequence_number_treatment ::
                                  • 0 :
                                • Date_received : 19911231
                                  • Sequence_number_outcome ::
                                      • 0 : 1. O
                                • 1 ::
                                    • Patient_sequence_number : 1
                                      • Sequence_number_treatment ::
                                          • 0 :
                                        • Date_received : 19911231
                                          • Sequence_number_outcome ::
                                              • 0 : 1. O
                                    • Product_problem_flag : Y
                                      • Date_report_to_fda : 19911223
                                        • Manufacturer_country :
                                          • Manufacturer_g1_address_2 :
                                            • Manufacturer_g1_address_1 :
                                              • Distributor_zip_code :
                                                • Report_date : 19911223
                                                  • Date_report_to_manufacturer : 19911219
                                                    • Manufacturer_contact_city :
                                                      • Distributor_address_2 :
                                                        • Date_facility_aware : 19911218
                                                          • Single_use_flag :
                                                            • Manufacturer_contact_plocal :
                                                              • Event_location : HOSPITAL
                                                                • Manufacturer_contact_address_2 :
                                                                  • Manufacturer_g1_state :
                                                                    • Manufacturer_contact_phone_number :
                                                                      • Manufacturer_name :
                                                                        • Distributor_address_1 :
                                                                          • Date_of_event : 19911218
                                                                            • Manufacturer_contact_extension :
                                                                              • Report_source_code : User Facility report
                                                                                • Distributor_state :
                                                                                  • Remedial_action ::
                                                                                      • 0 :
                                                                                    • Number_devices_in_event :
                                                                                      • Manufacturer_contact_zip_ext :
                                                                                        • Date_received : 19911231
                                                                                          • Manufacturer_g1_zip_code_ext :
                                                                                            • Mdr_text ::
                                                                                                • 0 ::
                                                                                                    • Patient_sequence_number : 1
                                                                                                      • Text : DURING SURGICAL PROCEDURE, OHMEDA ELECTRONIC VENTILATOR FAILED TO OPERATE. ANESTHESIOLOGIST PROCEEDED TO MANUALLY VENTILATE THE PATIENT. SURGICAL PROCEDURE WAS INTERRUPTED DURING MANUAL VENTILATION. VENTILATOR WAS RESET ACCORDING TO MANUFACTER'S DIRECTIONS, AND ELECTRONIC VENTILATOR WAS AGAIN PUT INTO USE. THE VENTILATOR CONTINUED TO FUNCTION IN AN ACCEPTABLE MANNER, AND THE CASE WAS COMPLETED WITHOUT FURTHER DIFFICULTY. A BARD 5000 ELECTROSURGICAL UNIT WAS IN USE AT THE TIME. ROUTING OF CABLES, LEADS, ETC, UNFORTUNATELY, CANNOT BE DUPLICATED AT THIS TIME. FIELD MODIFICATION TO CORRECT THIS PROBLEM HAS BEEN DEVELOPED BY MFR. OUR FACILITY IS WARY OF POTENTIAL FOR FUTURE FAILUREDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-91. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: FAILURE TO CYCLE, TELEMETRY FAILURE, NONE OR UNKNOWN, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
                                                                                                        • Text_type_code : Description of Event or Problem
                                                                                                          • Mdr_text_key : 20436222
                                                                                                    • Reprocessed_and_reused_flag :
                                                                                                      • Type_of_report ::
                                                                                                          • 0 : Initial submission
                                                                                                        • Manufacturer_zip_code_ext :
                                                                                                          • Manufacturer_contact_country :
                                                                                                            • Health_professional :
                                                                                                              • Manufacturer_contact_area_code :
                                                                                                                • Event_key :
                                                                                                                  • Manufacturer_g1_zip_code :
                                                                                                                    • Manufacturer_g1_country :
                                                                                                                      • Manufacturer_contact_pcity :
                                                                                                                        • Mdr_report_key : 186
                                                                                                                          • Distributor_city :
                                                                                                                            • Date_report : 19911223
                                                                                                                              • Manufacturer_zip_code :
                                                                                                                                • Manufacturer_contact_l_name :
                                                                                                                                  • Manufacturer_g1_postal_code :
                                                                                                                                    • Previous_use_code :
                                                                                                                                      • Manufacturer_contact_f_name :
                                                                                                                                        • Manufacturer_address_1 :
                                                                                                                                          • Manufacturer_contact_address_1 :
                                                                                                                                            • Manufacturer_contact_state :
                                                                                                                                              • Manufacturer_address_2 :
                                                                                                                                                • Manufacturer_state :
                                                                                                                                                  • Distributor_name :
                                                                                                                                                    • Reporter_occupation_code :
                                                                                                                                                      • Manufacturer_contact_exchange :
                                                                                                                                                        • Source_type ::
                                                                                                                                                            • 0 :
                                                                                                                                                          • Device ::
                                                                                                                                                              • 0 ::
                                                                                                                                                                  • Lot_number : N/A
                                                                                                                                                                    • Manufacturer_d_country :
                                                                                                                                                                      • Manufacturer_d_zip_code_ext :
                                                                                                                                                                        • Manufacturer_d_postal_code :
                                                                                                                                                                          • Device_event_key : 182
                                                                                                                                                                            • Baseline_510_k__exempt_flag :
                                                                                                                                                                              • Device_operator : OTHER HEALTH CARE PROFESSIONAL
                                                                                                                                                                                • Generic_name : VENTILATOR, ANESTHESIA
                                                                                                                                                                                  • Openfda ::
                                                                                                                                                                                      • Regulation_number : 868.5895
                                                                                                                                                                                        • Medical_specialty_description : Anesthesiology
                                                                                                                                                                                          • Device_class : 2
                                                                                                                                                                                            • Device_name : Ventilator, Continuous, Facility Use
                                                                                                                                                                                          • Model_number : 7810
                                                                                                                                                                                            • Date_received : 19911231
                                                                                                                                                                                              • Device_evaluated_by_manufacturer :
                                                                                                                                                                                                • Manufacturer_d_zip_code :
                                                                                                                                                                                                  • Baseline_510_k__flag :
                                                                                                                                                                                                    • Device_sequence_number : 1
                                                                                                                                                                                                      • Device_age_text : 01-JUL-91
                                                                                                                                                                                                        • Brand_name : OHMEDA
                                                                                                                                                                                                          • Baseline_510_k__number :
                                                                                                                                                                                                            • Manufacturer_d_state :
                                                                                                                                                                                                              • Other_id_number : CE# 1979
                                                                                                                                                                                                                • Implant_flag : N
                                                                                                                                                                                                                  • Manufacturer_d_address_2 :
                                                                                                                                                                                                                    • Catalog_number : 1500-8000-000
                                                                                                                                                                                                                      • Manufacturer_d_address_1 :
                                                                                                                                                                                                                        • Manufacturer_d_city :
                                                                                                                                                                                                                          • Manufacturer_d_name : OHMEDA
                                                                                                                                                                                                                            • Device_availability : Yes
                                                                                                                                                                                                                              • Date_removed_flag :
                                                                                                                                                                                                                                • Device_report_product_code : CBK
                                                                                                                                                                                                                          • Report_to_manufacturer :
                                                                                                                                                                                                                            • Manufacturer_contact_zip_code :
                                                                                                                                                                                                                              • Manufacturer_link_flag : N
                                                                                                                                                                                                                                • Adverse_event_flag : N
                                                                                                                                                                                                                                  • Report_to_fda : Y
                                                                                                                                                                                                                                    • Removal_correction_number :
                                                                                                                                                                                                                                      • Manufacturer_contact_postal_code :
                                                                                                                                                                                                                                        • Distributor_zip_code_ext :
                                                                                                                                                                                                                                          • Initial_report_to_fda :
                                                                                                                                                                                                                                            • Manufacturer_postal_code :
                                                                                                                                                                                                                                              • Manufacturer_contact_pcountry :

Device Adverse Events

  • 3 ::
      • Manufacturer_contact_t_name :
        • Manufacturer_g1_name :
          • Number_patients_in_event :
            • Manufacturer_g1_city :
              • Event_type : Death
                • Manufacturer_city :
                  • Report_number : 132
                    • Patient ::
                        • 0 ::
                            • Patient_sequence_number : 1
                              • Sequence_number_treatment ::
                                  • 0 :
                                • Date_received : 19911231
                                  • Sequence_number_outcome ::
                                      • 0 : 1. D
                                • 1 ::
                                    • Patient_sequence_number : 1
                                      • Sequence_number_treatment ::
                                          • 0 :
                                        • Date_received : 19911231
                                          • Sequence_number_outcome ::
                                              • 0 : 1. D
                                    • Product_problem_flag : N
                                      • Date_report_to_fda : 19911219
                                        • Manufacturer_country :
                                          • Manufacturer_g1_address_2 :
                                            • Manufacturer_g1_address_1 :
                                              • Distributor_zip_code :
                                                • Report_date : 19911219
                                                  • Date_report_to_manufacturer : 19911219
                                                    • Manufacturer_contact_city :
                                                      • Distributor_address_2 :
                                                        • Date_facility_aware : 19911213
                                                          • Single_use_flag :
                                                            • Manufacturer_contact_plocal :
                                                              • Event_location : HOSPITAL
                                                                • Manufacturer_contact_address_2 :
                                                                  • Manufacturer_g1_state :
                                                                    • Manufacturer_contact_phone_number :
                                                                      • Manufacturer_name :
                                                                        • Distributor_address_1 :
                                                                          • Date_of_event : 19911213
                                                                            • Manufacturer_contact_extension :
                                                                              • Report_source_code : User Facility report
                                                                                • Distributor_state :
                                                                                  • Remedial_action ::
                                                                                      • 0 :
                                                                                    • Number_devices_in_event :
                                                                                      • Manufacturer_contact_zip_ext :
                                                                                        • Date_received : 19911231
                                                                                          • Manufacturer_g1_zip_code_ext :
                                                                                            • Mdr_text ::
                                                                                                • 0 ::
                                                                                                    • Patient_sequence_number : 1
                                                                                                      • Text : DURING REPAIR FRACTURED HIP, PATIENT BECAME HYPOTENSIVE AT TIME OF APPLICATION OF BONE CEMENT, METHYL METHACRYLATE. POST -OPERATIVE HEAD CAT SCAN REVEALED LARGE INFARCT CEREBELLUM. PATIENT EXPIRED THE FOLLOWING DAY. KNOW ADVERSE REACTION OF METHYL METHACRYLATE INCLUDE: CEREBROVASCULAR ACCIDENT, MYOCARDIAL INFARCTION, CARDIAC ARREST, SUDDEN DEATHDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.
                                                                                                        • Text_type_code : Description of Event or Problem
                                                                                                          • Mdr_text_key : 46
                                                                                                    • Reprocessed_and_reused_flag :
                                                                                                      • Type_of_report ::
                                                                                                          • 0 : Initial submission
                                                                                                        • Manufacturer_zip_code_ext :
                                                                                                          • Manufacturer_contact_country :
                                                                                                            • Health_professional :
                                                                                                              • Manufacturer_contact_area_code :
                                                                                                                • Event_key :
                                                                                                                  • Manufacturer_g1_zip_code :
                                                                                                                    • Manufacturer_g1_country :
                                                                                                                      • Manufacturer_contact_pcity :
                                                                                                                        • Mdr_report_key : 132
                                                                                                                          • Distributor_city :
                                                                                                                            • Date_report : 19911219
                                                                                                                              • Manufacturer_zip_code :
                                                                                                                                • Manufacturer_contact_l_name :
                                                                                                                                  • Manufacturer_g1_postal_code :
                                                                                                                                    • Previous_use_code :
                                                                                                                                      • Manufacturer_contact_f_name :
                                                                                                                                        • Manufacturer_address_1 :
                                                                                                                                          • Manufacturer_contact_address_1 :
                                                                                                                                            • Manufacturer_contact_state :
                                                                                                                                              • Manufacturer_address_2 :
                                                                                                                                                • Manufacturer_state :
                                                                                                                                                  • Distributor_name :
                                                                                                                                                    • Reporter_occupation_code :
                                                                                                                                                      • Manufacturer_contact_exchange :
                                                                                                                                                        • Source_type ::
                                                                                                                                                            • 0 :
                                                                                                                                                          • Device ::
                                                                                                                                                              • 0 ::
                                                                                                                                                                  • Lot_number : UNKNOWN
                                                                                                                                                                    • Manufacturer_d_country :
                                                                                                                                                                      • Manufacturer_d_zip_code_ext :
                                                                                                                                                                        • Manufacturer_d_postal_code :
                                                                                                                                                                          • Device_event_key : 130
                                                                                                                                                                            • Baseline_510_k__exempt_flag :
                                                                                                                                                                              • Device_operator : OTHER HEALTH CARE PROFESSIONAL
                                                                                                                                                                                • Generic_name : METHYL METHACRYLATE
                                                                                                                                                                                  • Openfda ::
                                                                                                                                                                                      • Regulation_number : 882.5030
                                                                                                                                                                                        • Medical_specialty_description : Neurology
                                                                                                                                                                                          • Device_class : 2
                                                                                                                                                                                            • Device_name : Methyl Methacrylate For Aneurysmorrhaphy
                                                                                                                                                                                          • Model_number :
                                                                                                                                                                                            • Date_received : 19911231
                                                                                                                                                                                              • Device_evaluated_by_manufacturer :
                                                                                                                                                                                                • Manufacturer_d_zip_code :
                                                                                                                                                                                                  • Baseline_510_k__flag :
                                                                                                                                                                                                    • Device_sequence_number : 1
                                                                                                                                                                                                      • Device_age_text :
                                                                                                                                                                                                        • Brand_name : SURGICAL SIMPLEX P
                                                                                                                                                                                                          • Baseline_510_k__number :
                                                                                                                                                                                                            • Manufacturer_d_state :
                                                                                                                                                                                                              • Other_id_number : UNKNOWN
                                                                                                                                                                                                                • Implant_flag : Y
                                                                                                                                                                                                                  • Manufacturer_d_address_2 :
                                                                                                                                                                                                                    • Catalog_number :
                                                                                                                                                                                                                      • Manufacturer_d_address_1 :
                                                                                                                                                                                                                        • Manufacturer_d_city :
                                                                                                                                                                                                                          • Manufacturer_d_name : HOWMEDICA
                                                                                                                                                                                                                            • Device_availability : No
                                                                                                                                                                                                                              • Date_removed_flag :
                                                                                                                                                                                                                                • Device_report_product_code : JXH
                                                                                                                                                                                                                          • Report_to_manufacturer :
                                                                                                                                                                                                                            • Manufacturer_contact_zip_code :
                                                                                                                                                                                                                              • Manufacturer_link_flag : N
                                                                                                                                                                                                                                • Adverse_event_flag : Y
                                                                                                                                                                                                                                  • Report_to_fda : Y
                                                                                                                                                                                                                                    • Removal_correction_number :
                                                                                                                                                                                                                                      • Manufacturer_contact_postal_code :
                                                                                                                                                                                                                                        • Distributor_zip_code_ext :
                                                                                                                                                                                                                                          • Initial_report_to_fda :
                                                                                                                                                                                                                                            • Manufacturer_postal_code :
                                                                                                                                                                                                                                              • Manufacturer_contact_pcountry :

Device Adverse Events

  • 4 ::
      • Manufacturer_contact_t_name :
        • Manufacturer_g1_name :
          • Number_patients_in_event :
            • Manufacturer_g1_city :
              • Event_type : Malfunction
                • Manufacturer_city :
                  • Report_number : 187
                    • Patient ::
                        • 0 ::
                            • Patient_sequence_number : 1
                              • Sequence_number_treatment ::
                                  • 0 :
                                • Date_received : 19911231
                                  • Sequence_number_outcome ::
                                      • 0 : 1. O
                                • 1 ::
                                    • Patient_sequence_number : 1
                                      • Sequence_number_treatment ::
                                          • 0 :
                                        • Date_received : 19911231
                                          • Sequence_number_outcome ::
                                              • 0 : 1. O
                                    • Product_problem_flag : Y
                                      • Manufacturer_country :
                                        • Manufacturer_g1_address_2 :
                                          • Manufacturer_g1_address_1 :
                                            • Distributor_zip_code :
                                              • Mdr_report_key : 187
                                                • Manufacturer_contact_city :
                                                  • Distributor_address_2 :
                                                    • Date_facility_aware : 19911215
                                                      • Single_use_flag :
                                                        • Manufacturer_contact_plocal :
                                                          • Event_location : HOSPITAL
                                                            • Manufacturer_contact_address_2 :
                                                              • Manufacturer_g1_state :
                                                                • Manufacturer_contact_phone_number :
                                                                  • Manufacturer_name :
                                                                    • Distributor_address_1 :
                                                                      • Date_of_event : 19911204
                                                                        • Manufacturer_contact_extension :
                                                                          • Report_source_code : User Facility report
                                                                            • Distributor_state :
                                                                              • Remedial_action ::
                                                                                  • 0 :
                                                                                • Number_devices_in_event :
                                                                                  • Manufacturer_contact_zip_ext :
                                                                                    • Date_received : 19911231
                                                                                      • Manufacturer_g1_zip_code_ext :
                                                                                        • Mdr_text ::
                                                                                            • 0 ::
                                                                                                • Patient_sequence_number : 1
                                                                                                  • Text : PT. HAD INTERNAL FIXATION OF BASILAR NECK FRACTURE L. FEMUR APPROX. 1 YEAR AGO. HASDEVELOPED PROGRESSIVE COLLAPSE AT THE ARE OF THE FRACTURE WITH SUBSEQUENT PROTRUSION OF THE PIN INTO THE LATERA ASPECT OF ACETABULUM. PHYSICIAN NOTATION ON HISTORY AND PHYSICAL STATES. IMPLANT FAILURE WITH PROTRUSION OF HARDWARE, LEFT HIPINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.
                                                                                                    • Text_type_code : Description of Event or Problem
                                                                                                      • Mdr_text_key : 178
                                                                                                • Reprocessed_and_reused_flag :
                                                                                                  • Type_of_report ::
                                                                                                      • 0 : Initial submission
                                                                                                    • Manufacturer_zip_code_ext :
                                                                                                      • Manufacturer_contact_country :
                                                                                                        • Health_professional :
                                                                                                          • Manufacturer_contact_area_code :
                                                                                                            • Event_key :
                                                                                                              • Manufacturer_g1_zip_code :
                                                                                                                • Manufacturer_g1_country :
                                                                                                                  • Manufacturer_contact_pcity :
                                                                                                                    • Distributor_city :
                                                                                                                      • Manufacturer_zip_code :
                                                                                                                        • Manufacturer_contact_l_name :
                                                                                                                          • Manufacturer_g1_postal_code :
                                                                                                                            • Previous_use_code :
                                                                                                                              • Manufacturer_contact_f_name :
                                                                                                                                • Manufacturer_address_1 :
                                                                                                                                  • Manufacturer_contact_address_1 :
                                                                                                                                    • Manufacturer_contact_state :
                                                                                                                                      • Manufacturer_address_2 :
                                                                                                                                        • Manufacturer_state :
                                                                                                                                          • Distributor_name :
                                                                                                                                            • Reporter_occupation_code :
                                                                                                                                              • Manufacturer_contact_exchange :
                                                                                                                                                • Source_type ::
                                                                                                                                                    • 0 :
                                                                                                                                                  • Device ::
                                                                                                                                                      • 0 ::
                                                                                                                                                          • Lot_number : UNKNOWN
                                                                                                                                                            • Manufacturer_d_country :
                                                                                                                                                              • Manufacturer_d_zip_code_ext :
                                                                                                                                                                • Manufacturer_d_postal_code :
                                                                                                                                                                  • Device_event_key : 183
                                                                                                                                                                    • Baseline_510_k__exempt_flag :
                                                                                                                                                                      • Device_operator : OTHER
                                                                                                                                                                        • Generic_name : METAL PIN, LEFT HIP
                                                                                                                                                                          • Openfda ::
                                                                                                                                                                              • Regulation_number : 888.3040
                                                                                                                                                                                • Medical_specialty_description : Orthopedic
                                                                                                                                                                                  • Device_class : 2
                                                                                                                                                                                    • Device_name : Pin, Fixation, Smooth
                                                                                                                                                                                  • Model_number : UNKNOWN
                                                                                                                                                                                    • Date_received : 19911231
                                                                                                                                                                                      • Device_evaluated_by_manufacturer :
                                                                                                                                                                                        • Manufacturer_d_zip_code :
                                                                                                                                                                                          • Baseline_510_k__flag :
                                                                                                                                                                                            • Device_sequence_number : 1
                                                                                                                                                                                              • Device_age_text :
                                                                                                                                                                                                • Brand_name : UNKNOWN
                                                                                                                                                                                                  • Baseline_510_k__number :
                                                                                                                                                                                                    • Manufacturer_d_state :
                                                                                                                                                                                                      • Other_id_number : UNKNOWN
                                                                                                                                                                                                        • Implant_flag : Y
                                                                                                                                                                                                          • Manufacturer_d_address_2 :
                                                                                                                                                                                                            • Catalog_number : UNKNOWN
                                                                                                                                                                                                              • Manufacturer_d_address_1 :
                                                                                                                                                                                                                • Manufacturer_d_city :
                                                                                                                                                                                                                  • Manufacturer_d_name : UNKNOWN
                                                                                                                                                                                                                    • Device_availability : No answer provided
                                                                                                                                                                                                                      • Date_removed_flag :
                                                                                                                                                                                                                        • Device_report_product_code : HTY
                                                                                                                                                                                                                  • Report_to_manufacturer :
                                                                                                                                                                                                                    • Manufacturer_contact_zip_code :
                                                                                                                                                                                                                      • Manufacturer_link_flag : N
                                                                                                                                                                                                                        • Adverse_event_flag : N
                                                                                                                                                                                                                          • Report_to_fda : Y
                                                                                                                                                                                                                            • Removal_correction_number :
                                                                                                                                                                                                                              • Manufacturer_contact_postal_code :
                                                                                                                                                                                                                                • Distributor_zip_code_ext :
                                                                                                                                                                                                                                  • Initial_report_to_fda :
                                                                                                                                                                                                                                    • Manufacturer_postal_code :
                                                                                                                                                                                                                                      • Manufacturer_contact_pcountry :