BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1001219 · Received February 22, 2008

    Report

    Report Number
    2126677-2008-00014
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE TABLE FOOTSWITCH WAS DEFECTIVE. THE FE REPLACED THE FOOTSWITCH AND RETURNED THE PRODUCT BACK TO SERVICE. PREVENTIVE MAINTENANCE PROCEDURES ARE CURRENTLY IN PLACE PER THE SYSTEM'S PERIODIC MAINTENANCE MANUAL THAT INCLUDES INSTRUCTIONS TO INSPECT THE CONDITION AND FUNCTIONALITY OF TABLE CONTROL PEDALS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPAX 40E TABLE WAS MOVING FREELY. 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 A MOVING TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 2147506 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA