BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1371260 · Received February 6, 2009

    Report

    Report Number
    9613445-2009-00006
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 9, 2009
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND A MISALIGNED FOOT PEDAL, RESULTING IN A SIMULATED FLOAT COMMAND. THE FE ADJUSTED THE FOOT PEDAL AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS WERE NOT ACTUATING, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE SITUATION WAS DISCOVERED DURING SETUP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEUS XR/A KPR GE HANGWEI MEDICAL SYSTEMS, CO., LTD. 2259988 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA