BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTOR (COMPAX 40E)

    MDR report key: 1181423 · Received September 24, 2008

    Report

    Report Number
    2126677-2008-00071
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND A DAMAGED WIRING LOOM THAT INTERMITTENTLY INTERRUPTED THE POWER BEING SUPPLIED TO THE TABLE LOCKS, PREVENTING THE LOCKS FROM ENGAGING. THE FE REPAIRED THE CABLE AND RETURNED TO THE SYSTEM TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE TOP TO UNEXPECTEDLY FREE FLOAT IN BOTH THE LATERAL AND LONGITUDINAL DIRECTIONS. NO INJURY WAS 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 VECTOR (COMPAX 40E) IZZ GE MEDICAL SYSTEMS, LLC 12339A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA