BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LS450 TOILET LIFT

    MDR report key: 17735361 · Received September 13, 2023

    Report

    Report Number
    17735361
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 12, 2023
    Report Date
    September 8, 2023
    Manufacturer
    LIFTSEAT CORPORATION INC.
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS PIVOTING AS A 2 PERSON TRANSFER WITH WALKER AND GAIT BELT TO THE COMMODE. THE COMMODE WAS LOCKED, AND PATIENT WAS SITTING ON THE COMMODE WHEN IT STARTED TO SLIDE OUT FROM UNDER THEM AND THE PATIENT FELL TO THE FLOOR (LS450 TOILET LIFT). UPON INVESTIGATION/TESTING, IT WAS FOUND THAT THE PATIENT RIGHT REAR CASTER BRAKE IS NOT ENGAGING. ALL OTHER CASTERS ENGAGE INTO BRAKE AND WORK PROPERLY. THE SET SCREW ON THE BRAKE ROD THAT RUNS TO THE REAR CASTER IS NO LONGER ATTACHED CAUSING THE BRAKE TO NOT ENGAGE. THERE ARE NO VISUAL CUES THAT LET THE USER KNOW THE CHAIR LOCK IS BROKEN. STAFF WOULD HAVE TO RECOGNIZE THE EQUIPMENT'S MINOR MOVEMENT WHILE IN USE AND KNOW THIS INDICATES AN ISSUE WITH THE BRAKES. THE CHAIR MUST BE FLIPPED UPSIDE DOWN TO CHECK BRAKE FUNCTIONALITY (NOT SOMETHING THE UNIT CAN EASILY DO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059824 LS450 TOILET LIFT ADAPTOR, HYGIENE ILS LIFTSEAT CORPORATION INC. LS450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R