BEUDAMED
    FDA Adverse Event Death Summary report: N

    500 LB SMART LIFT WITH SCALE

    MDR report key: 21400531 · Received February 18, 2025

    Report

    Report Number
    2183887-2025-00001
    Event Type
    Death
    Date Received
    February 18, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 17, 2025
    Manufacturer
    EZ WAY INC
    Product Code
    FSA
    UDI-DI
    00848914000057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MET WITH (B)(6). WE WENT INTO THEIR SIMULATOR ROOM THAT HAD A DUMMIE IN THE BED. THEY HAD THE DUMMIE HOOKED UP TO THE MACHINE WITH ALL 4 STRAPS DOUBLE LOOPED. THEY SAID THAT THEY DO NOT DOUBLE LOOP AND DID NOT KNOW WHY IT WAS THAT WAY. I STRESSED THE DIFFERENCES OF THE STRAPS HAD TO DO WITH POSITIONING. IN THE ROOM THEY HAD THE SLING AND LIFT THAT WAS USED IN THE EVENT. LIFT AND SLING INSPECTED - TESTED OK. *L500PS-03 - 140966, THE MACHINE DID NOT HAVE ANY VISIBLE ISSUES. 50578 - 162245, MEDIUM MESH SLING WITH HEAD SUPPORT, DID NOT SEE ANY ISSUES WITH THE SLING- ALL LOOPS WERE INTACT. OPERATION MANUAL, PG 6. STEP 4 - NUMBER 2.

    Description of Event or Problem · 0

    RESIDENT HAD PRIOR CARE PROVIDED BY A NURSE. WHILE STILL IN BED, THE CNA AND CMA PUT THE SLING UNDER THE RESIDENT. THE CNA AND CMA HOOKED UP THE SLING TO THE LIFT AND BACKED THE LIFT AWAY FROM THE BED. THE LEFT LEG STRAP CAME LOOSE, THE LEFT LEG WAS RELEASED AND THE RESIDENT FELL OUT OF THE SLING AND HIT HER HEAD ON THE GROUND. THE RIGHT LEG STAYED IN SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670392 500 LB SMART LIFT WITH SCALE LIFT FSA EZ WAY INC L500PS-03 00848914000057

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death