BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMATPRO

    MDR report key: 5842672 · Received August 3, 2016

    Report

    Report Number
    5842672
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    May 12, 2016
    Report Date
    July 28, 2016
    Manufacturer
    REGULATORY INSIGHT, INC. (HOCOMA AG)
    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 USING LOKOMAT, HAD PATIENT IN HARNESS AND STRAPPED INTO ORTHOTIC. ATTEMPTED TO START MACHINE, AND FOUR ERROR CODES WERE GENERATED. ATTEMPTED TO RESTART, SAME ERROR CODES GENERATED, REQUIRING REBOOT OF THE MACHINE. THE PATIENT WAS REMOVED FROM THE DEVICE, AND UNABLE TO COMPLETE THE TREATMENT. NO INJURY TO THE PATIENT, NO POTENTIAL FOR INJURY TO THE PATIENT. PRIOR TO REBOOT, ATTEMPTED TO RUN THE MACHINE WITHOUT A PATIENT IN IT, AND SAME ERROR CODES WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495049 LOKOMATPRO SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK REGULATORY INSIGHT, INC. (HOCOMA AG) LOKOMATPRO

    Patients

    Seq Age Sex Outcome Treatment
    1