BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1060004 · Received June 11, 2008

    Report

    Report Number
    9613445-2008-00015
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND A DIRTY PRINTED CIRCUIT BOARD (PCB) THAT SIMULATED AN ON-STATE COMMAND OF THE FOOT PEDAL, PREVENTING THE TABLE LOCKS FROM ACTUATING. THE FE CLEANED THE PCB AND VERIFIED THAT THE TABLE WAS OPERATING PER SPECS.

    Description of Event or Problem · 1

    THE PROTEUS XR/A TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO AXES WITHOUT RESISTANCE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD POTENTIALLY CONTRIBUTE TO A SERIOUS INJURY IF A PT WAS TO BECOME UNSTEADY AND 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