BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1418554 · Received March 30, 2009

    Report

    Report Number
    2126677-2009-00020
    Event Type
    Malfunction
    Date Received
    March 30, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 3, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE CHIEF TECHNOLOGIST SAID THE LOCK PEDAL AREA WAS CLEANED AFTER THE EVENT TO REMOVE ANY FOREIGN MATERIAL THAT MAY HAVE BEEN INTERFERING WITH THE PEDAL MOTION. THE GE FIELD ENGINEER INSPECTED THE TABLE LOCK MECHANISM AND PEDAL AREA AND WAS ABLE TO REMOVE SOME DEBRIS FROM THE PEDAL AREAS, BUT WAS NOT ABLE TO REPRODUCE THE PROBLEM, BUT FELT DEBRIS WAS THE MOST LIKELY CAUSE. HE TESTED THE TABLE OPERATIONS, FOUND NO OTHER PROBLEMS AND RETURNED THE ROOM TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE WITHOUT RESISTANCE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS (FREE FLOAT). THE INCIDENT WAS OBSERVED WHILE AFTER A PATIENT WAS LOADED ONTO THE TABLE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING 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 46-216697P3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR