BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION

    MDR report key: 1895679 · Received October 28, 2010

    Report

    Report Number
    1895679
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 28, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE ON A PATIENT, A PHILIPS VISION BIPAP UNIT HAD (ALTERNATING CURRENT) AC POWER LOSS OF LESS THAN 10 SECONDS AND DID NOT RETURN TO VENTILATION MODE. AFTER POWER LOSS, THE UNIT PERFORMED A SELF TEST AND DISPLAYED "LOSS OF AC POWER" ON THE TEST SCREEN BUT DID NOT RESUME VENTILATION. A VISION UNIT WITH SOFTWARE REVISION 13.8 IS EXPECTED TO RESUME VENTILATION AT THE MODES AND SETTINGS THAT ARE IN EFFECT PRIOR TO POWER LOSS, REGARDLESS OF THE DURATION OF POWER LOSS. THIS DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP VISION BIPAP BZD PHILIPS HEALTHCARE 582059 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *