BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1361327 · Received January 13, 2009

    Report

    Report Number
    2126677-2009-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    December 15, 2008
    Report Date
    December 15, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND DEBRIS IN THE PEDAL THAT WAS KEEPING IT ACTIVATED, PREVENTING THE LOCKS FROM ENGAGING. THE FE CLEARED THE DEBRIS AND VERIFIED THAT THE PEDAL AND TABLE LOCKS WERE OPERATING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE TECHNOLOGIST RELEASED THE FOOT PEDAL, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LATERAL AND LONGITUDINAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SET-UP. 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 40E IZZ GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1