BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1196979 · Received October 8, 2008

    Report

    Report Number
    2126677-2008-00078
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 12, 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

    DURING EVAL OF THE SYSTEM, THE FIELD ENGINEER (FE) WAS UNABLE TO DUPLICATE THE PROBLEM. THE FE VERIFIED THAT THE TABLE WAS FUNCTIONING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLETOP UNEXPECTED MOVED BIDIRECTIONALLY WITHOUT RESISTANCE (FREE FLOAT) DURING LOADING OF A PT. THE TECHNOLOGIST HAD TO PROP THE TABLE TO STABILIZE IT FOR THE PT. AFTER THE PT WAS REMOVED FROM THE TABLE, IT WAS REPORTED THAT THE LOCKS WERE FUNCTIONING PROPERLY. THERE WAS NO REPORT THAT THE PT FELL NOR AN INJURY OCCURRED. THE UNEXPECTED FLOAT 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. DURING AN INTERVIEW WITH THE GE FIELD ENGINEER, THE TECHNOLOGIST INDICATED THAT SHE WAS NOT AWARE OF THE MECHANICAL INTERLOCK FEATURE OF THE TABLE TO RESTRICT THE MOTION IN THE LATERAL DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 45434237 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA