BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI CHAIR

    MDR report key: 8269190 · Received January 22, 2019

    Report

    Report Number
    3009481053-2019-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 13, 2018
    Report Date
    November 1, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS INDICATE THAT THE WHEEL DETACHMENT WAS MOST LIKELY CAUSED BY USER ERROR. IF THE DEVICE IS USED WITH THE WHEEL BOLT LOCKED, THE FORCE EXERTED ON THE WHEEL BY THE LOCKING MECHANISM COULD CAUSE THE WHEEL TO UNTHREAD. ADDITION OF LOCTITE TO THE WHEEL BOLTS IMPROVES WHEEL FIXATION AND PRODUCT RELIABILITY ACCORDING TO RISK ANALYSIS. MANUFACTURER HAS INITIATED UPGRADE OF TECHNICAL DOCUMENTATION AND PRODUCTION SPECIFICATIONS TO ENSURE THAT LOCTITE IS APPLIED TO THE DEVICE WHEEL BOLTS IN PRODUCTION. MANUFACTURER WILL CONTINUE TO MONITOR THIS TYPE OF EVENT AND TAKE APPROPRIATE ACTIONS AS NEEDED.

    Description of Event or Problem · 0

    WHEEL DETACHED FROM THE DEVICE LEG DURING PATIENT TRANSFER FROM BATHROOM TO BED CAUSING THE DEVICE TO TILT.

    Description of Event or Problem · 1

    WHEEL DETACHED FROM THE THE DEVICE LEG DURING PATIENT TRANSFER FROM BATHROOM TO BED CAUSING THE DEVICE TO TILT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58847 COMBI CHAIR CHAIR WITH CASTERS INM HANDICARE AB 201911314

    Patients

    Seq Age Sex Outcome Treatment
    1