BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1301359 · Received December 30, 2008

    Report

    Report Number
    9613445-2008-00055
    Event Type
    Malfunction
    Date Received
    December 30, 2008
    Date of Event
    December 3, 2008
    Report Date
    December 3, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    P993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND THAT THE REPORTED FLOAT WAS CAUSED BY MISADJUSTED OPTICAL FLAG THAT PREVENTED IT FROM INTERCEPTING THE LIGHT BEAM WHICH WOULD SIGNAL THE LOCKS TO ACTUATE. 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 DID NOT ACTUATE WHEN THE TECHNOLOGIST RELEASED THE FOOT PEDAL, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LATERAL AND LONGITUDINAL 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 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