BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1140570 · Received August 28, 2008

    Report

    Report Number
    9613445-2008-00026
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THE FOOTSWITCH FLAG THAT CUTS THE LIGHT BEAM WAS OUT OF ADJUSTMENT, PREVENTING THE TABLE LOCKS FROM ENGAGING. THE FE RE-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, CAUSING THE TABLETOP TO MOVE IN TWO DIRECTIONS WITHOUT RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT NOR INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA