BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1204588 · Received October 20, 2008

    Report

    Report Number
    2126677-2008-00085
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 16, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND A BLOWN 2-AMP FUSE. WHEN THE FE REPLACED THE FUSE, IT WAS VERIFIED THAT THE LOCKS WERE PERFORMING ACCORDING TO SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH THE LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE PROBLEM WAS DISCOVERED AS THE OPERATOR WAS POSITIONING THE PT. THERE WAS NO REPORT OF A FALL OR INJURY. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1