BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE GAIT ACTIVE 360 DYNAMIC MOBILITY TRAINER

    MDR report key: 19426441 · Received May 30, 2024

    Report

    Report Number
    3030997791-2024-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 30, 2024
    Manufacturer
    DIH TECHNOLOGIES INC.
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN THIS LOT WAS 1 OF 4 MANUFACTURED BY A SUPPLIER NO LONGER USED BY DIH. THE ASSEMBLY OF THE SPREADER BAR HAS MOVED TO OUR OWN MANUFACTURING FACILITY WHERE QA PROCEDURES ARE IN PLACE TO DETECT DEFECTIVE SELF-LOCKING NUTS. SINCE THE SUSPECT LOT OF DEVICES HAVE BEEN INSPECTED, WE HAVE DETERMINED THAT IT IS IMPROBABLE FOR THIS EVENT TO REOCCUR.

    Description of Event or Problem · 0

    DIH TECHNOLOGIES, INC. RECEIVED A REPORT STATING THE CENTER BOLT ON YOKE OF THE SPREADER BAR BECAME DETACHED DURING A PATIENT SESSION. THE CAREGIVER WAS ABLE TO STABILIZE THE PATIENT DURING THE EVENT. NO ADVERSE EVENT OCCURRED. THE SPREADER BAR WAS REPLACED ON THIS DEVICE. THE SPREADER BAR ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PRIMARY ROOT CAUSE WAS DETERMINED THAT THE SELF-LOCKING NUT DESIGNED TO PREVENT THE SPREADER BAR FROM DETACHING WAS DEFECTIVE. THE DEFECTIVE NUT WAS FOUND TO HAVE GAPS THAT WERE OUT OF SPECIFICATION. THESE GAPS DID NOT ALLOW THE PROPER ENGAGEMENT WITH THE CENTER BOLT. IN NORMAL OPERATION, THE SPREADER BAR CAN SPIN 360 DEGREES ON A BEARING THAT IS INSTALLED ABOVE THE SELF-LOCKING NUT. SINCE THE SELF-LOCKING NUT WAS NOT ENGAGING WITH THE BOLT SUFFICIENTLY, EXPECTED FORCES APPLIED FROM THE PATIENT'S WEIGHT ALLOWED THE NUT TO BACK-OFF AS THE SPREADER BAR ROTATED. SPREADER BAR ASSEMBLIES FROM THIS LOT WERE INSPECTED FOR DEFECTIVE NUTS AND NO ADDITIONAL DEFECTS WERE FOUND. THE ANNUAL MAINTENANCE RECORDS OF ALL OTHER FIELD UNITS DO NOT SHOW ANY DEFECTIVE NUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100180 SAFE GAIT ACTIVE 360 DYNAMIC MOBILITY TRAINER POWERED EXERCISE EQUIPMENT BXB DIH TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown