BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT-SYSTEM

    MDR report key: 598264 · Received April 27, 2005

    Report

    Report Number
    3003781275-2005-00001
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    April 15, 2005
    Report Date
    April 22, 2005
    Manufacturer
    HOCOMA AG
    Product Code
    ISD
    Removal / Correction Number
    3003781275-04-22-2005-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FOLLOWING 20 MINUTES OF TRAINING A MOTOR COMPLETE, CHRONIC SPINAL CORD INJURED PATIENT AT 2.8KM/HR AND AT 55KG OF BODY-WEIGHT SUPPORT, THE UNLOADING ROPE BROKE. THE LOCATION OF THE BREAK WAS APPROXIMATELY 16 INCHES ABOVE THE HORIZONTAL CORSS BAR LOCATED ABOVE THE SUBJECT. THE LOCATION OF THE BREAK ON THE ROPE APPEARED TO BE AT ABOUT THE POSITION THE ROPE WOULD BE EXPECTED TO BE ON THE OVER-HEAD PULLEY. INSPECTION OF THE ROPE AT THE LOCATION OF THE BREAK REVEALED A BRITTLE TEXTURE, AS THE ROPE HAD BEEN SUBJECTED TO HIGH TEMPERTURES AS MIGHT OCCUR UNDER FRICTION CONDITIONS. NO INJURIES RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOKOMAT-SYSTEM POWERED EXERCISE EQUIPMENT ISD HOCOMA AG 4.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other