BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUSRS

    MDR report key: 2992449 · Received February 26, 2013

    Report

    Report Number
    2992449
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD JUST COMPLETED A CONTINUOUS PASSIVE MOTION (CPM) ACTIVITY WITH THE BTE EQUIPMENT. THE THERAPIST WAS LOOKING UP THE REPORT WITH THE TOTAL RANGE WHEN THE HEAD UNLOCKED, DROPPING THE TOOL IN A DOWNWARD ARC. PATIENT WAS STILL IN THE MACHINE AT THE TIME. THE MACHINE DID NOT BEEP TO INDICATE THAT IT WAS GOING TO UNLOCK AND THE BUTTON YOU PUSH TO EITHER UNLOCK/LOCK THE MACHINE CONTINUED TO DISPLAY "UNLOCK" INDICATING IT NEEDED TO BE PUSHED TO UNLOCK THE MACHINE. THE PATIENT WAS STARTLED AND COMPLAINED OF SOME DISCOMFORT OVER THE RADIAL ASPECT OF THE WRIST AROUND THE THUMB CARPOMETACARPAL JOINT. THE MACHINE IS NOW MARKED OUT OF SERVICE. THE PATIENT FELT OK AT THE END OF THE SESSION. THE DEVICE ALSO FAILED TO BOOT-UP PROPERLY THEN NEXT TIME IT WAS TURNED ON.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HAND THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81347 PRIMUSRS EXERCISER BXB BTE TECHNOLOGIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR