BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1344318 · Received February 3, 2009

    Report

    Report Number
    9613445-2009-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Date of Event
    December 2, 2008
    Report Date
    December 2, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND THAT THE ACTUATOR ARM IN THE FOOT PEDAL ASSEMBLY WAS OUT OF ALIGNMENT, SIMULATING A FLOAT COMMAND. THE FE REPLACED THE PEDAL ACTUATORS 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 FOOT PEDAL WAS RELEASED, CAUSING TO THE TABLETOP TO MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE INCIDENT WAS DISCOVERED DURING A PATIENT EXAM. 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 BE 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK