BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMATPRO

    MDR report key: 9639487 · Received January 28, 2020

    Report

    Report Number
    3003781275-2020-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 28, 2020
    Manufacturer
    HOCOMA AG
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN ROPE WAS COLLECTED AND EXAMINED; VISUAL TRACES OF ABRASION OF THE ROPE INDICATE A WEAR AND TEAR FRACTION. ROOT CAUSE ANALYSIS ONGOING. DEVICE IS AND WILL REMAIN OUT OF SERVICE. TECHNICIAN FROM THE AUTHORISED REPRESENTATIVE IN (B)(6) IMMEDIATELY VISITED THE SITE AND LOCKED THE DEVICE. THE ROPE WAS COLLECTED AND THE DEVICE REMAINS LOCKED FOR ANY TRAININGS. TESTS TO SIMULATE THE INCIDENT SET UP AT THE MANUFACTURER FOR ROOT CAUSE ANALYSIS SIMULATION AND ENDURANCE TESTS ARE CURRENTLY BEING PERFORMED. (B)(4) TECHNICIAN VISITS SITE FOR FURTHER ROOT CAUSE ANALYSIS OF THE INCIDENT.

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE TRAINING SESSION, THE PATIENT WAS LIFTED UP BY THE BODY WEIGHT SUPPORT SYSTEM CONNECTED TO A SUPPORT ROPE, SUPPORT FRAME AND TO THE HARNESS OF THE PATIENT. THE SUPPORT ROPE BROKE WHILE THE PATIENT WAS AT THE HEIGHT OF 20CM ABOVE THE TREADMILL BELT, THE PATIENT AND HARNESS FELL DOWN. THE THERAPIST WAS STILL ASSISTING THE PATIENT DURING SETUP AND WAS ABLE TO SUPPORT THE PATIENT AFTER THE ROPE BROKE TO PREVENT THE PATIENT FROM FALLING. THE PATIENT DID NOT SUFFER ANY INJURIES. THE PATIENT WAS SECURED BY THE THERAPIST. DEVICE TAKEN OUT OF SERVICE. NO FURTHER MEDICAL INTERVENTIONS WERE NECESSARY FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103303 LOKOMATPRO ISOKINETIC TESTING AND EVALUATION SYSTEM IKK HOCOMA AG LOKOMATPRO L6.2 AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other