BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4102953 · Received September 19, 2014

    Report

    Report Number
    2031642-2014-01073
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 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

    DURING PREVENTIVE MAINTENANCE SERVICE, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR FAILED BATTERY TESTING DURING PERFORMANCE VERIFICATION. THE FSE INFORMED THE CUSTOMER OF THE BATTERY TEST FAILURE AND THE CUSTOMER REPORTED THE BATTERY WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. POWER FAILURE DUE TO LOSS OF BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION. TO REDUCE THE RISK OF POWER FAILURE THE USER MUST PAY CLOSE ATTENTION TO THE BATTERY CHARGE LEVEL. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584975 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1