BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3232558 · Received July 18, 2013

    Report

    Report Number
    2031642-2013-00346
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 7, 2013
    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 INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR BEGAN ALARMING AND THE DISPLAY WENT DARK, AND THE UNIT THEN STOPPED OPERATING. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED AN PRIOR OCCURRENCE OF A POWER ISSUE THAT INDICATED THE VENTILATOR SHUTDOWN WHILE IN NORMAL VENTILATION MODE AND POWER WAS THEN RESTORED. THE VENTILATOR HAD BEEN PREVIOUSLY OPERATING ON THE INTERNAL BATTERY. DURING EVALUATION OF THE DEVICE, THE MANUFACTURERS SERVICE TECHNICIAN REPORTED THE DEVICE WOULD NOT POWER ON. THE SERVICE TECHNICIAN REPORTED OBSERVING A COMPONENT FAILURE ON THE POWER MANAGEMENT PCB BOARD. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT BOARD. APPLICABLE FINAL TESTING WAS PERFORMED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336191 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1