{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-30", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5011919", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20090713", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20090622", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20090723", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090713", "brand_name": "GE AESPIRE 7900", "generic_name": "ANESTHESIA VENTILATOR OR ANESTHESIA DELIVERY SYS", "manufacturer_d_name": "GE", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MADISON", "manufacturer_d_state": "WI", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "AESPIRE 7900", "catalog_number": "", "lot_number": "", "other_id_number": "1009-9012-000", "device_availability": "Yes", "device_report_product_code": "BSZ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ], "product_problems": [ "No Audible Alarm", "Detachment Of Device Component" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20090713", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "105", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Venipuncture", "Low Oxygen Saturation" ] } ], "distributor_city": "", "date_report": "20090713", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1414910", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "1270756", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE VENTILATOR ALARMS DID NOT RESET TO A DEFAULT SETTING. THE DISCONNECT ALARM HAD BEEN TURNED DOWN TO AN INAUDIBLE SETTING DURING A PREVIOUS PROCEDURE. THE PT BECAME DISCONNECTED FROM THE VENTILATOR AND THIS WAS NOT IMMEDIATELY RECOGNIZED DUE TO THE INAUDIBLE ALARM. THE PT WAS SCHEDULED FOR A LAPAROSCOPIC CHOLECYSTECTOMY WHICH WAS THEN LATER CONVERTED TO AN OPEN CHOLECYSTECTOMY DUE TO DIFFICULTY IN PERFORMING THE PROCEDURE LAPAROSCOPICALLY. DURING THE COURSE OF THE PROCEDURE, THERE WAS SIGNIFICANT BLEEDING AND A NEW BLOOD SAMPLE WAS NEEDED FOR TYPE AND CROSSMATCH, AS WELL AS A NEW LARGE-BORE IV FOR POSSIBLE BLOOD TRANSFUSION. SINCE ONE ARM WAS TUCKED TO THE SIDE DURING THE INITIAL ATTEMPT USING THE LAPAROSCOPIC APPROACH, ONLY THE LEFT ARM WAS AVAILABLE FOR DRAWING BLOOD AND IV PLACEMENT. AFTER PLACEMENT OF A TOURNIQUET AROUND THE ARM, THE OXYGEN SATURATION ON THE MONITOR DECREASED, AS EXPECTED, DUE TO THE RESTRICTED CIRCULATION. ATTEMPTS TO MONITOR THE OXYGEN SATURATION ELSEWHERE WAS UNSUCCESSFUL. UPON COMPLETION OF THE IV PLACEMENT/BLOOD DRAWING, THE ENDOTRACHEAL TUBE WAS NOTED TO BE DISCONNECTED FROM THE VENTILATOR CIRCUIT. THIS WAS NOT IMMEDIATELY RECOGNIZED BECAUSE THE DISCONNECT ALARM HAD BEEN TURNED DOWN TO THE MINIMUM AUDIBLE LEVEL BY SOMEONE DURING A PREVIOUS PROCEDURE AND DID NOT RESET." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }