BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM

    MDR report key: 11194423 · Received January 19, 2021

    Report

    Report Number
    2031642-2021-00194
    Event Type
    Death
    Date Received
    January 19, 2021
    Date of Event
    January 10, 2021
    Report Date
    January 12, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:11FEB2021. B4:19FEB2021. THE BIPAP FOCUS IS AN END OF LIFE. A LETTER DATED 25JUL2014 NOTIFIED CUSTOMERS THAT "NON-CE MARKETS WILL BE DISCONTINUED ON DECEMBER 31, 2014". THE HOSPITAL'S BIOMEDICAL ENGINEER REMOVED THE DEVICE FROM SERVICE. THIS REPORTER STATED THAT A PATIENT OF UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF CORONAVIRUS (COVID-19). NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) THERAPY VIA THE RESPIRONICS V60 VENTILATOR; PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE, THE DEVICE GENERATED OVER PRESSURE CONDITION (41), DISCONNECT (639), HI P REG (640), AND APNEA (644) ALARM, THE PATIENT EXPERIENCED AN EVENT OF RESPIRATORY DISTRESS, THE PATIENT UNDERWENT AN INTUBATION PROCEDURE; DETAILS NOT REPORTED, AND WAS ADMINISTERED MECHANICAL VENTILATION; DETAILS NOT REPORTED. NO RELEVANT LABORATORY DATA WAS REPORTED. THE OUTCOME OF THE ADVERSE EVENT WAS NOT REPORTED. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. THE DEVICE IS AN END OF LIFE DURABLE MEDICAL EQUIPMENT WHOSE SUPPORT AND SERVICE STOPPED UP TO FIVE YEARS AFTER DECEMBER 31, 2014. G4:12FEB2021. B4:19FEB2021. THIS PATIENT WITH MULTIPLE CO-MORBIDITIES; NOT SPECIFIED, WAS ADMITTED TO THE HOSPITAL WITH AN ADMITTING DIAGNOSIS OF CORONAVIRUS (COVID 19). WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE, THE PATIENT¿S CONDITION CHANGED AND THEY EXPERIENCED AN EVENT OF ACUTE RESPIRATORY DISTRESS SYNDROME, THE DEVICE GENERATED OVER PRESSURE CONDITION (41), DISCONNECT (639), HI P REG (640), AND APNEA (644) ALARM, THE PATIENT EXPERIENCED AN EVENT OF RESPIRATORY DISTRESS, THE PATIENT UNDERWENT AN INTUBATION PROCEDURE; DETAILS NOT REPORTED, AND WAS ADMINISTERED MECHANICAL VENTILATION; DETAILS NOT REPORTED. POST INTUBATION ON (B)(6) 2021, THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THIS REPORTER STATED THAT THE DEVICE¿S BEHAVIOR WAS DUE TO THE RESPIRATORY DISTRESS SYNDROME. THE CAUSE OF DEATH WAS NOT REPORTED. THE PATIENT EXPIRED UNRELATED TO A VENTILATOR MALFUNCTION. 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.

    Additional Manufacturer Narrative · 0

    G4: 25FEB2021. B4: 25FEB2021. THE DEVICE IN USE AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT WAS A BI-PAP FOCUS. 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.

    Additional Manufacturer Narrative · 0

    G4:(B)(6) 2021. B4:(B)(6) 2021. H10: THE REPORTER STATED THAT THE PATIENT'S OUTCOME WAS RELATED TO THERE ADMITTING DIAGNOSIS AND MULTIPLE CO-MORBIDITIES. THERE WAS NO ALLEGATION AGAINST THE BI-PAP FOCUS AND THE PATIENT'S OUTCOME. 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.

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2021. REPORT DATE: 19JAN2021.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD AN UNKNOWN MALFUNCTION WHILE IN USE ON A PATIENT. THE DEVICE WAS USE AT THE TIME OF THE EVENT. A GOOD FAITH EFFORT WAS BEEN MADE AND IT WAS STATED THAT MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92843 BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER| UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER