BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1031362 · Received April 17, 2008

    Report

    Report Number
    2126677-2008-00029
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND DEBRIS UNDER THE LEFT FOOT PEDAL, WHICH PREVENTED THE LOCKING MECHANISM FROM ENGAGING. THE FE CLEANED THE FOOT PEDAL ASSEMBLY, ADJUSTED THE SWITCH ON THE LEFT PEDAL, AND VERIFIED TABLE LOCK FUNCTIONALITY. PROCEDURES ARE CURRENTLY IN PLACE PER THE PREVENTATIVE MAINTENANCE MANUAL TO INSPECT THE CONDITION AND FUNCTIONALITY OF CONTROL PEDALS AND MOVEMENT INHIBIT BUTTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPAX 40E TABLE LOCKS WERE NOT HOLDING, CAUSING THE TABLE TO MOVE FREELY IN ALL AXIS. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF THE FREE TABLE MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 2225881 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA