BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ WAY SMART LIFT

    MDR report key: 20249831 · Received September 18, 2024

    Report

    Report Number
    2183887-2024-00005
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 18, 2024
    Manufacturer
    EZ WAY, INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) SPOKE WITH (B)(6) ABOUT THE GREENIES. (B)(6) CONFIRMED THE PURPOSE OF THE GREEN CAPS ARE TO COVER ANY UNEVEN AREAS ON THE TIPS OF THE SLING HANGER BARS. THE GREEN CAPS DON'T HAVE ANYTHING TO DO WITH SAFETY OR KEEPING THE SLING LOOPS ON THE BARS. (B)(6) ASKED STAFF TO RE-CREATE THE INCIDENT, AND THEY COULD NOT TELL HIM HOW THE RESIDENT FELL. STAFF TOLD (B)(6) THEY INSPECTED THE SLING AND FOUND NOTHING WRONG WITH IT. WHEN THEY SAW THE LIFT AFTER THE INCIDENT, THE SLING WAS HOOKED UP TO THE LIFT. STAFF TOLD (B)(6) THE SHOULDER LOOPS WERE DOUBLE-LOOPED. (B)(6) STRESSED THE SLING LOOPS SHOULD NOT BE DOUBLE-LOOPED AND ONLY A SINGLE LOOP SHOULD BE ON EACH HANGER BAR HOOK.

    Description of Event or Problem · 0

    2 STAFF MEMBERS LIFTED THE RESIDENT OUT OF A RECLINER TO PUT IN A BED. DURING THE TRANSFER ACROSS BEDROOM FLOOR, THE RESIDENT FELL FROM SLING. (B)(6) SAID A LITTLE GREEN CAP CAME OFF A HANGER BAR. THERE WAS NO OBSTRUCTION IN THE PATH OF THE UNIT AND THERE WAS NO EXCESSIVE MOVEMENT DURING THE TRANSFER. THE RESIDENT WENT TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344350 EZ WAY SMART LIFT MOBILE LIFT FSA EZ WAY, INC L600PS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| L| H