BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1311017 · Received January 11, 2009

    Report

    Report Number
    9613445-2009-00012
    Event Type
    Malfunction
    Date Received
    January 11, 2009
    Date of Event
    December 1, 2008
    Report Date
    December 1, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) FOUND THAT THE FLAG IN THE PEDAL ASSEMBLY WAS NOT ALIGNED PROPERLY RELATIVE TO THE OPTO-COUPLER, SIMULATING A CONSTANT FLOAT COMMAND. THE FE ADJUSTED THE FLAG AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS WERE NOT ACTUATING WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). 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 PT. 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