BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2013723 · Received March 10, 2011

    Report

    Report Number
    2031642-2011-00064
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 19, 2010
    Report Date
    February 18, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GAS DELIVERY SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG NOTED THE VENTILATOR RESTARTED BUT WAS UNABLE TO COMPLETE POWER ON SELF TEST AND RESUME VENTILATION. THE MANUFACTURER'S SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT PCB BOARD AND GAS DELIVERY SYSTEM WITH CABLE TO COMPLETE THE REPAIR. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    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