BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT

    MDR report key: 8280867 · Received January 28, 2019

    Report

    Report Number
    3003781275-2019-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 15, 2019
    Report Date
    June 26, 2019
    Manufacturer
    HOCOMA AG
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL INVESTIGATION: ROOT-CAUSE ANALYSIS COMPLETED. THE ROPE WAS TESTED INTERNALLY AND ITS QUALITY IS NOT IN QUESTION. THE DEFECT WAS CLEARLY CAUSED BY INCORRECT INSTALLATION OF THE ROPE. THE SERVICE TECHNICIAN WAS IMPROPERLY TRAINED ON THIS AFFECTED CONFIGURATION. CORRECTIVE ACTION: A NEW ROPE WAS INSTALLED, THE DEVICE WAS TESTED SUCCESSFULLY AND CAN BE USED AS BEFORE THE EVENT. THE SERVICE TECHNICIAN WAS RE-TRAINED. IN ADDITION, THE SERVICE MANUAL OF THE DEVICE WAS UPDATED, STANDARDIZED AND ILLUSTRATED WITH PICTURES/WARNINGS. PREVENTIVE ACTION: THE SERVICE TECHNICIAN WAS RETRAINED, AND HE CARRIED OUT ANOTHER ROPE REPLACEMENT UNDER REVIEW. HOCOMA CONSTRUCTIVELY CHANGED THE METAL BAR OVER WHICH THE ROPE WAS MISTAKENLY GUIDED, SO THAT A WRONG ROPE INSERTION CAN BE FURTHER AVOIDED FOR NEWLY PRODUCED DEVICES. THIS IS A FINAL REPORT. ALL OF THE ABOVE IDENTIFIED CORRECTIVE AND PREVENTIVE ACTIONS HAVE ALREADY BEEN IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE BROKEN ROPE WAS SENT BACK TO THE MANUFACTURER FOR EXAMINATION. RESULT OF THE EXAMINATION WAS THAT THE DEFECT WAS CAUSED BY WRONG INSERTION OF THE ROPE AFTER REPLACEMENT. THE DEVICE HAD BEEN MOVED BY HOCOMA SERVICE TECHNICIAN ONE WEEK BEFORE THIS EVENT. THE ROPE HAS BEEN INSTALLED ACROSS A METAL BAR INSTEAD OF BEING PULLED THROUGH A FEEDTHROUGH UNDERNEATH THIS BAR. AS A RESULT OF THIS INCREASED FRICTION, THE ROPE BROKE SOON AFTER TAKING THE DEVICE INTO SERVICE AGAIN.

    Description of Event or Problem · 1

    AT THE END OF THE TRAINING SESSION, THE PATIENT IS LIFTED TO BE TAKEN OUT OF THE DEVICE. BODY WEIGHT SUPPORT ROPE BREAKS WHILE LIFTING PATIENT UP. PATIENT (M, (B)(6) YR, (B)(6) KG) DROPS SLIGHTLY. IS CAUGHT BY CLINICIAN AND PUSHED UP. TWO OTHER CLINICIANS CAME TO HELP. PATIENT SUFFERED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73524 LOKOMAT SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK HOCOMA AG LOKOMATPRO L6.1

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR