BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4231276 · Received November 6, 2014

    Report

    Report Number
    2031642-2014-01368
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    REPIRONICS 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

    DURING DEVICE SERVICE, THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED CODES INDICATING A PRESSURE SENSORS/SUPPLY FAILURE. THE FAILURES AS NOTED MAY RESULT IN VENT INOP/SHUTDOWN OF THE DEVICE DURING NORMAL VENTILATION OPERATION. THE FSE REPLACED THE CPU AND MOTOR CONTROLLER PCB BOARDS TO ADDRESS THE FINDING. FACTORY ANALYSIS OF THE MOTOR CONTROLLER PCB BOARD REVEALED A CAPACITOR FAILURE THAT RESULTED IN THE NOTED POWER ISSUE. TESTING OF THE CPU PCB BOARD IDENTIFIED NO FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714339 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT REPIRONICS CALIFORNIA, INC V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1