BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY WEIGHT SUPPORT LIGHT

    MDR report key: 8540056 · Received April 23, 2019

    Report

    Report Number
    3006750942-2019-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 23, 2019
    Manufacturer
    MOTEK MEDICAL B.V.
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED AND PRECISE INFORMATION ABOUT EVENT AND PATIENT INFORMATION FROM CUSTOMER IS STILL MISSING. WE HAVE ATTEMPTED TO GET ADDITIONAL INFORMATION FROM CUSTOMER SEVERAL TIMES VIA EMAIL AND PHONE, BUT UNTIL NOW, INFORMATION WAS NOT PROVIDED. FURTHER ANALYSIS ACCORDING TO INSPECTION DETAILS ARE THEREFORE ONGOING. ROOT CAUSE ANALYSIS IS NOT COMPLETED.

    Description of Event or Problem · 1

    DURING A TREATMENT SESSION (GAIT REHABILITATION), THE YOKE (ATTACHMENT POINT OF THE PATIENT HARNESS) OF THE MEDICAL DEVICE (BODY WEIGHT SUPPORT (BWS) LIGHT) CAME LOOSE AND FELL OFF. THE PATIENT DID NOT GET INJURED. POSSIBLE RISK IS THAT THE YOKE DURING TREATMENT CAN DETACH AND FALL TO THE PATIENT HEAD FROM DISTANCE OF ABOUT 15 CM, WHICH CAN BE VERY DANGEROUS FOR SPECIFIC PATIENT POPULATION (PATIENTS AFTER RECENT CRANIOTOMY/CRANIECTOMY SURGERY). IT IS IMPORTANT TO NOTE THAT PATIENT HARNESS IS ALSO ATTACHED TO A SAFETY LINE TO PREVENT PATIENTS FROM FALLING, AND THIS SAFETY SYSTEM WAS NOT AFFECTED AND STAYED OPERATIONAL THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335861 BODY WEIGHT SUPPORT LIGHT POWERED EXERCISER BXB MOTEK MEDICAL B.V. RB011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention