BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1191927 · Received October 1, 2008

    Report

    Report Number
    9613445-2008-00035
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND THE ARM IN THE TABLE'S PEDAL MECHANISM WAS BENT, PREVENTING THE LOCKS FROM ENGAGING. THE FE SUSPECTED THE PEDAL MAY HAVE BEEN ABNORMALLY STRUCK AS IT WAS ONE OF THE REAR PEDALS THAT DOES NOT OTHERWISE GET MUCH USE. HE ADJUSTED THE PEDAL ARM AND TESTED THE SYSTEM. THE TABLE IS NOW WORKING PROPERLY.

    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. THE SITE WAS STILL ABLE TO USE THE TABLE DURING LOADING BY USING THE INHIBIT SWITCH AS AN ALTERNATE MEANS TO LOCK THE TABLE. HOWEVER, THE ISSUE WITH THE PEDAL MECHANISM PRESENTED THE POTENTIAL FOR AN UNEXPECTED TABLE MOVEMENT. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING 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