BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3870568 · Received June 12, 2014

    Report

    Report Number
    2031642-2014-00486
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 11, 2014
    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 THE MOTOR CONTROLLER AND POWER MANAGEMENT PCB BOARDS REVEALED SHORTED COMPONENTS WHICH MAY RESULT IN A LOSS OF THE 12 VOLT SUPPLY. IF THE NOTED FAILURE WERE TO OCCUR DURING OPERATION OF THE DEVICE DURING USE IN NORMAL VENTILATION, A VENT INOPERATIVE CONDITION COULD OCCUR. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. IF IN USE, THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348012 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1