BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 400

    MDR report key: 1311013 · Received January 11, 2009

    Report

    Report Number
    9611343-2009-00007
    Event Type
    Malfunction
    Date Received
    January 11, 2009
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) FOUND THAT THE UNEXPECTED FLOAT WAS DUE TO LOSS OF POWER TO THE TABLE LOCKS. THE POWER LOSS WAS CAUSED BY A BROKEN CABLE. THE FE REPLACED THE CABLE AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS WERE NOT ACTUATING WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SET-UP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTED TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSURING INSTABILITY COULD LEAD TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 400 IZZ GE MEDICAL SYSTEMS S.C.S. 46-909330G01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA