BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3882552 · Received June 19, 2014

    Report

    Report Number
    2031642-2014-00513
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 21, 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

    DURING OPERATIONAL CHECKOUT AFTER PREVENTIVE MAINTENANCE SERVICE OF THE DEVICE, THE MANUFACTURERS SERVICE ENGINEER REPORTED A DATA ACQUISITION FAILURE. A DATA ACQUISITION FAILURE DURING NORMAL VENTILATION OPERATION MAY RESULT IN A VENT INOP OCCURRENCE. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE SERVICE ENGINEER REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE TO ADDRESS THE FINDING. FINAL CHECK WAS COMPLETED WITH NO FAULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362068 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1