BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3953963 · Received July 23, 2014

    Report

    Report Number
    2031642-2014-00718
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE VENTILATOR WAS TURNED ON THE DISPLAY IS BLANK AND KEEPS ALARMING. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT. THE MANUFACTURERS SERVICE TECHNICIAN COULD NOT DUPLICATE THE REPORTED ISSUE, BUT REPLACED THE POWER MANAGEMENT BOARD AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431689 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1