BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 400

    MDR report key: 1196978 · Received October 8, 2008

    Report

    Report Number
    2126677-2008-00079
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND THAT THE FOOT PEDAL WAS OUT OF ADJUSTMENT THAT CAUSED THE SWITCHES TO STAY ACTIVATED. CONSEQUENTLY, THE PEDAL MECHANISM CONTINUOUSLY SENT THE FLOAT COMMAND, PREVENTING THE LOCKS FROM ENGAGING. A SECOND FE WAS DISPATCHED TO THE SITE TO REPAIR THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LATERAL AND LONGITUDINAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THERE WAS NO INJURY REPORTED. 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 400 IZZ GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1