BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1172093 · Received September 18, 2008

    Report

    Report Number
    9613445-2008-00034
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE PEDAL MECHANISM FLAG THAT INTERCEPTS THE LIGHT BEAM WAS OUT OF ADJUSTMENT, PREVENTING THE TABLE LOCKS TO ENGAGE. THE FE READJUSTED THE FLAG, AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE AFTER THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP TO MOVE IN TWO DIRECTIONS WITHOUT RESISTANCE. THE INCIDENT OCCURRED DURING PT SET-UP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY, IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING 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