BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2840008 · Received November 20, 2012

    Report

    Report Number
    2031642-2012-00508
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 12, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF A RETURNED POWER MANAGEMENT PCB BOARD REVEALED FAILED COMPONENTS ON THE BOARD RESULTING IN A 35V SUPPLY FAILURE. THE NOTED FAILURE CAN RESULT IN A SHUTDOWN OF THE VENTILATOR DURING USE IN NORMAL VENTILATION MODE. UPON LOSS OF POWER, A POWER FAIL ALARM WILL ACTIVATE AND ALTERNATIVE VENTILATION SHOULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1