BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3892894 · Received June 24, 2014

    Report

    Report Number
    2031642-2014-00547
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY DOES NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT. IF A LOSS OF POWER OCCURS DURING USE IT COULD CAUSE THE UNIT TO SHUT DOWN DUE TO BACK-UP BATTERY NOT WORKING. THE SERVICE TECH REPLACED THE BATTERY TO ADDRESS THE REPORTED PROBLEM. THE UNIT PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368593 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1