BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS GS

    MDR report key: 2163061 · Received July 6, 2011

    Report

    Report Number
    2163061
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 6, 2011
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    MACHINE FAILED LEAK TEST. CHECKED ALL HOSES AND REPLACED PATIENT CIRCUIT, BUT DEVICE STILL HAD MASSIVE LEAK. REMOVED MACHINE FROM ROOM TO TROUBLESHOOT. ABLE TO TROUBLESHOOT PROBLEM TO A PIECE OF PLASTIC STUCK IN THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE. THE PIECE WAS REMOVED AND THE VALVE WAS REASSEMBLED. THE LEAK TEST WAS RUN 3 TIMES AND UNIT PASSED ALL TIMES. DEVICE WAS RUN ON A BAG, THE UNIT IS OPERATIONAL AND OKAY TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS GS GAS-MACHINE, ANESTHESIA BSZ DRAEGER MEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *