BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2833964 · Received November 15, 2012

    Report

    Report Number
    2031642-2012-00502
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 2, 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 THE MOTOR CONTROLLER PCB BOARDS REVEALED A COMPONENT FAILURE WHICH MAY RESULT IN A SHORT OUT 12V_OVP, WHICH WOULD DISABLE THE BLOWER. 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
    1 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1