BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS

    MDR report key: 10421080 · Received August 12, 2020

    Report

    Report Number
    10421080
    Event Type
    Death
    Date Received
    August 12, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 11, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, AT APPROX 7:10 PM, THE IV THERAPIST NOTICED THE PT'S BIPAP MACHINE WAS NOT WORKING (BLACK SCREEN AND WOULD NOT POWER ON DESPITE BEING PLUGGED INTO A RED ELECTRICAL OUTLET). THE BIPAP MACHINE WAS REPLACED AND WITHIN MINS AND THE PT'S OXYGEN LEVELS INCREASED FROM THE 70'S TO TO THE 80'S, BUT HE CONTINUED TO HAVE DIFFICULTY BREATHING. PATIENT RAPIDLY DETERIORATED, UNEXPECTEDLY IN THE SETTING OF CHALLENGES WITH THE FUNCTIONING OF THE MEDICAL DEVICES (BIPAP) AND ULTIMATELY DIED. SEE PHILIPS JUNE 25 2020 LETTER: UPDATE ON FIELD ACTION - PHILIPS V60 VENTILATORS MAY SHUT DOWN UNEXPECTEDLY DUE TO A PREMATURE COMPONENT FAILURE (FSN86600049); SEE PHILIPS MARCH 2020 URGENT - MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE; SEE PHILIPS EMAIL 8/11/2020 ATTACHED WITH PACKET. COVID-19 POSITIVE. THERAPY DATES: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864303 PHILIPS BIPAP (V 60 NON INVASIVE VENTILATOR) MNT PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death PHILIPS V60 NON-INVASIVE VENTILATOR.