BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, ISOKINETIC TESTING AND EVALUATION

    MDR report key: 14655183 · Received June 10, 2022

    Report

    Report Number
    3003781275-2022-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    June 10, 2022
    Product Code
    IKK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED CODES.

    Description of Event or Problem · 0

    DURING A CUSTOMER VISIT WITH THE SALES TEAM IN A THERAPY CENTER IN GERMANY, THE CLINICAL APPLICATIONS MANAGER WAS SHOWING THE BODY WEIGHT SUPPORT SYSTEM OF THE LOKOMATNANOS. HE TOOK THE COVER AWAY AND DETECTED THAT THE ROPE SHEAT WAS DAMAGED. NOBODY WAS INJURED. THE PATIENT ROPE WAS MISGUIDED IN THE LOWER PART OF THE WEIGHT SUPPORT UNIT DURING INSTALLATION, WHICH CAUSED THE ROPE TO COME IN CONTACT WITH AN ALUMINIUM PROFILE AND RUB AGAINST IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889545 SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown