BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1195524 · Received October 2, 2008

    Report

    Report Number
    9613445-2008-00037
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND AN ACTUATOR IN THE PEDAL MECHANISM THAT WAS OUT OF ADJUSTMENT THAT PREVENTED THE SENSOR FLAG TO BREAK THE LIGHT BEAM, AS INTENDED. CONSEQUENTLY, THE PEDAL MECHANISM CONTINUOUSLY SENT THE FLOAT COMMAND, PREVENTING THE LOCKS FROM ENGAGING. THE FE CORRECTED THE PROBLEM AND VERIFIED THAT THE TABLE WAS PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE DUE TO AN ISSUE WITH THE PEDAL MECHANISM, CAUSING THE TABLETOP TO MOVE IN BOTH DIRECTIONS WITHOUT RESISTANCE. 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