BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT

    MDR report key: 5515914 · Received March 22, 2016

    Report

    Report Number
    5515914
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    October 22, 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 BEING RAISED IN THE LOKOMAT BY THE WINCH AND THE WINCH AUTOMATICALLY WENT DOWNWARD. STOP BUTTON NEEDED TO BE PUSHED. PATIENT WAS AMBULATING IN THE LOKOMAT AND ERROR MESSAGES CAME ON 4 TIMES WITHOUT ANY EXPLANATIONS. TREATMENT NEED TO BE STOPPED USING THE LOKOMAT LEGS. MANUFACTURER RESPONSE FOR EXERCISER, EXERCISER (PER SITE REPORTER): UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174601 LOKOMAT SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK REGULATORY INSIGHT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR