BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT

    MDR report key: 5515915 · Received March 22, 2016

    Report

    Report Number
    5515915
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    October 29, 2015
    Report Date
    February 15, 2016
    Manufacturer
    REGULATORY INSIGHT, INC.
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS REMOVED FROM THE EQUIPMENT, AND HOCOMA SUPPORT WAS CONTACTED. SUPPORT WALKED WRITER THROUGH A CALIBRATION PROCESS. THE PATIENT WAS AGAIN SET UP IN THE LOKOMAT, AND GAIT TRAINING WAS INITIATED. WITHIN 5 MIN OF STARTING TRAINING, THE LOKOMAT PC ALERTED THE USER THAT IT WAS "REBOOTING NOW". THE MACHINE SHUT DOWN WITH THE PATIENT ON THE TREADMILL WITHIN THE ROBOTIC SYSTEM. THE TWO ABOVE LISTED WITNESSES WERE CALLED TO ASSIST WITH REMOVAL OF THE PATIENT FROM THE SYSTEM. THE MANUAL/EMERGENCY RELEASE OF THE OVERHEAD HARNESS SYSTEM WAS INITIATED, BUT IT REQUIRED THE ADDITION OF WRITER'S WEIGHT ON THE HANGER/PULLEY IN ORDER TO LOWER THE PATIENT TO HIS WHEELCHAIR. THE SYSTEM WOULD NOT LOWER COMPLETELY TO THE WHEELCHAIR SEAT, BUT DISMOUNT WAS ABLE TO BE ACHIEVED WITH THE USE OF THE SEAT ELEVATOR FUNCTION ON THE PATIENT'S WHEELCHAIR. THE LOKOMAT SYSTEM COULD NOT BE RESTARTED ON THIS DAY. ====================== MANUFACTURER RESPONSE FOR EXERCISER, EXERCISER (PER SITE REPORTER) ====================== UNKNOWN. COMPANY IS AWARE OF ONGOING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174600 LOKOMAT SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK REGULATORY INSIGHT, INC. LOKOMAT PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR