BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2041677 · Received April 6, 2011

    Report

    Report Number
    2031642-2011-00101
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP WHILE IN USE ON PATIENT. THERE WAS NO PATIENT HARM REPORTED. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DEVICE DIAGNOSTIC LOG HISTORY NOTED A SHUT DOWN OF THE UNIT AND FAILURE TO SUCCESSFULLY RESTART INTO VENTILATION. THE SERVICE TECHNICIAN PERFORMED ELECTRICAL SAFETY TEST , HIGH PRESSURE LEAK TEST AND SYSTEM LEAK TEST AND THE UNIT PASSED ALL TEST. THE SERVICE TECH DIDN'T FIND ANY PROBLEM WITH THE UNIT. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1