BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT

    MDR report key: 5515916 · Received March 22, 2016

    Report

    Report Number
    5515916
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    November 9, 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

    WHEN ATTEMPTING TO INCREASE TREADMILL SPEED FROM 1 TO 1.1 MPH ON THE LOKOMAT, THE LEGS INCREASED SPEED DISPROPORTIONATELY TO THE TREADMILL. EQUIPMENT WAS STOPPED. RESTARTED AT 1.1 MPH WITHOUT PROBLEM, BUT AFTER ABOUT 30 SECONDS THE LOKOMAT STOPPED AND GAVE AN ERROR MESSAGE ABOUT THE SENSOR OF THE RIGHT HIP. MANUFACTURER RESPONSE FOR EXERCISER, EXERCISER (PER SITE REPORTER): HOCOMA IS SCHEDULED TO COME FOR REPAIR 11/11/2015. WILL PROVIDE INFORMATION REGARDING THIS NEW ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173823 LOKOMAT SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK REGULATORY INSIGHT, INC. LOKOMAT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR