{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 168 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "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": "Death", "report_number": "9610816-2020-00159", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200518", "manufacturer_address_2": "", "pma_pmn_number": "K130849", "date_of_event": "20200501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "USER FACI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200518", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "530721", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200518", "brand_name": "INTELLIVUE MX450 PATIENT MONITOR", "generic_name": "PATIENT MONITOR", "manufacturer_d_name": "PHILIPS MEDICAL SYSTEMS", "manufacturer_d_address_1": "HEWLETT-PACKARD STR.2", "manufacturer_d_address_2": "", "manufacturer_d_city": "BOEBLINGEN", "manufacturer_d_state": "", "manufacturer_d_zip_code": "71034", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "71034", "device_operator": "HEALTH PROFESSIONAL", "model_number": "866062 (MX450)", "catalog_number": "866062", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "MHX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00884838038769", "udi_public": "(01)00884838038769", "openfda": { "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ], "product_problems": [ "No Audible Alarm" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/01/2020;05/01/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20200518", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "86 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Death" ] } ], "distributor_city": "", "date_report": "20200501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10065202", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200501", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315495277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1 UPDATED SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT." }, { "mdr_text_key": "315499894", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3 AND H6: THE FIELD SUPPORT ENGINEER (FSE) WENT FOR ONSITE SERVICE. THE FSE REVIEWED THE LOG FILES FROM THE CENTRAL STATION (PIIC IX) AND SURVEILLANCE FILES WHICH THE CUSTOMER BIOMED RETRIEVED. NO ALARM OR INOP WAS FOUND ON THE LOG FILE OR SURVEILLANCE FILES. THE DEVICE SHOWS IT WAS OFFLINE 04AM, 7-7:30AM AND 10AM APPROXIMATELY DURING THE TIME IN QUESTION. AFTER ASKING THE CUSTOMER BIOMED ABOUT THIS PROBLEM, HE STATED THAT THE X3 WAS DOCKED TO THE MX450, WHICH KEPT INTERRUPTING THE CONNECTION, AND SINCE THIS DEVICE HAS NO WIRELESS COVERAGE, THE X3 DID NOT SEND AN ALARM TO THE CONTROL CENTER. DURING THE INVESTIGATION OF THE INTELLIVUE MX450 THE FSE TESTED THE SUSPECTED EQUIPMENT FOR ANY CONNECTION ISSUE BETWEEN THE X3 AND MX450. THE DEVICES-MAINTAINED CONNECTION FOR 2 DAYS AND NO DISCONNECT WAS EVER SEEN BETWEEN THE TWO DEVICES FOR THE ENTIRE TIME. IT HAS BEEN ESTABLISHED THAT THERE WAS NO TROUBLE FOUND DURING THE INVESTIGATION. THE ROOT CAUSE FOR THE REPORTED ISSUE REMAINS UNKNOWN. A MALFUNCTION AT THE TIME OF THE REPORTED ISSUE CANNOT BE RULED OUT. TO ENSURE CUSTOMER SATISFACTION, THE FSE REPLACED THE MSL ASSEMBLY AND THE MSL CABLE FOR PREVENTATIVE MAINTENANCE. AS THE PHILIPS FSE FOUND THE DEVICE TO BE OPERATING AS SPECIFIED AND EXPECTED, PHILIPS WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE DEVICE WORKED AS INTENDED. IT HAS BEEN ESTABLISHED THAT THERE WAS NO TROUBLE FOUND DURING THE INVESTIGATION. A MALFUNCTION AT THE TIME OF THE REPORTED ISSUE CANNOT BE RULED OUT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT." }, { "mdr_text_key": "191250149", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE." }, { "mdr_text_key": "191250150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER'S BIOMEDICAL ENGINEER REPORTED THAT ON (B)(6) 2020 THE INTELLIVUE MX450 PATIENT MONITOR WAS NOT ALARMING TO THE CENTRAL NURSES STATION AND A ALARM DID NOT SOUND AT THE CENTRAL STATION. THE PATIENT DIED." } ], "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": "07/14/2020;07/14/2020" } ] }