BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1198832 · Received October 14, 2008

    Report

    Report Number
    2126677-2008-00082
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) INSPECTED THAT TABLE AND FOUND A BLOWN F12 FUSE, CAUSING ALL THE TABLE LOCKS TO DISENGAGE. THE FE REPLACED THE FUSE AND TESTED ALL FUNCTIONS OF THE TABLE. THE FE VERIFIED THAT THE TABLE LOCKS WERE FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS WOULD NOT ACTUATE, CAUSING UNEXPECTED BIDIRECTIONAL MOTION OF THE TABLETOP WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SYSTEM POWER-UP IN PREPARATION FOR AN EXPOSURE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1