BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4182845 · Received October 17, 2014

    Report

    Report Number
    2031642-2014-01252
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 26, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL SERVICE TECH REPORTED THAT DURING SERVICING OF THE UNIT THE BATTERY NOT CHARGING. POWER FAILURE DUE TO LOSS OF BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION. THE INTERNATIONAL SERVICE TECH REPLACED THE BATTERY AND THE REPORTED PROBLEM RESOLVED. THE UNIT PASSED ALL APPLICABLE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661370 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1