BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1162225 · Received September 16, 2008

    Report

    Report Number
    2126677-2008-00068
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND NEEDLE CAPS STUCK UNDER THE PEDAL IN SUCH A WAY THAT THE SWITCH THAT COMMANDS THE LATERAL LOCKS WAS STUCK IN THE FLOAT MODE. THE FE CLEARED THE DEBRIS, AND THE TABLE WORKED AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LATERAL LOCKS DID NOT ACTIVATE CAUSING FREE TABLETOP MOTION IN THE LATERAL DIRECTION WITH NO RESISTANCE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PATIENT. 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 2225864 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA