{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 81996 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2249723-2020-00677", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K112372", "date_of_event": "20200412", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463607", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "CARDIOSAVE HYBRID TYPE B PLUG", "generic_name": "SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL", "manufacturer_d_name": "DATASCOPE CORP. - MAHWAH", "manufacturer_d_address_1": "1300 MACARTHUR BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAHWAH", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "07430", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "07430", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "0998-00-0800-53", "lot_number": "N/A", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "DSP", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2249723" ], "fei_number": [ "3001418283" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ], "product_problems": [ "Low Readings", "Low Readings" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/01/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "66", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200521", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001010", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200412", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193126227", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS." }, { "mdr_text_key": "193126228", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER CALLED FROM THE ICU REPORTING THAT SOMETIMES THE PUMP READS THE HEART RATE AT HALF OF WHAT THE ACTUAL RATE IS. THE PATIENT RHYTHM IS IRREGULAR, AND THE RATE IS AT TIMES NORMAL, THEN AT TIMES IT IS ABOVE 100. THE PUMP WILL SCROLL LEADS IN AUTO, THEN SWITCH TO PRESSURE TRIGGER OFTEN. IT IS IN PRESSURE TRIGGER WHEN THE RATE IS POSTED INCORRECTLY. THE CUSTOMER TRIED SWITCHING CABLES, ECG PADS, AND WAS ADVISED TRYING A DIFFERENT PUMP WHICH THEY ARE CONSIDERING. THEY SWITCHED TO SEMI AUTO AND WERE ABLE TO CHOOSE A DIFFERENT LEAD. THIS WORKED AND THE PUMP READS CORRECTLY, BUT THEY WERE VERY UNCOMFORTABLE TIMING THE PUMP AND DID NOT WANT TO LEAVE IN SEMI AUTO. THEY WILL CONTINUE IN AUTO FOR NOW AND CONSIDERING A DIFFERENT PUMP. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED." }, { "mdr_text_key": "317760385", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AT THIS TIME, THE CUSTOMER HAS NOT REQUESTED GETINGE TO EVALUATE THE IABP UNIT. HOWEVER, A GETINGE FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO PERFORM A SCHEDULE PREVENTIVE MAINTENANCE (PM) AND REPORTED THAT THE CUSTOMER DID NOT IMPLEMENT OF ANY PROBLEMS, AND THAT NO PROBLEMS WERE FOUND DURING THE PM. THE FSE COMPLETED THE PM WITH FULL CALIBRATION, FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE." }, { "mdr_text_key": "317760386", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CUSTOMER CALLED FROM THE ICU REPORTING THAT SOMETIMES THE PUMP READS THE HEART RATE AT HALF OF WHAT THE ACTUAL RATE IS. THE PATIENT RHYTHM IS IRREGULAR, AND THE RATE IS AT TIMES NORMAL, THEN AT TIMES IT IS ABOVE 100. THE PUMP WILL SCROLL LEADS IN AUTO, THEN SWITCH TO PRESSURE TRIGGER OFTEN. IT IS IN PRESSURE TRIGGER WHEN THE RATE IS POSTED INCORRECTLY. THE CUSTOMER TRIED SWITCHING CABLES, ECG PADS, AND WAS ADVISED TRYING A DIFFERENT PUMP WHICH THEY ARE CONSIDERING. THEY SWITCHED TO SEMI AUTO AND WERE ABLE TO CHOOSE A DIFFERENT LEAD. THIS WORKED AND THE PUMP READS CORRECTLY, BUT THEY WERE VERY UNCOMFORTABLE TIMING THE PUMP AND DID NOT WANT TO LEAVE IN SEMI AUTO. THEY WILL CONTINUE IN AUTO FOR NOW AND CONSIDERING A DIFFERENT PUMP. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED." } ], "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": "05/22/2020" } ] }