BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ WAY SMART LIFT

    MDR report key: 4417215 · Received January 2, 2015

    Report

    Report Number
    2183887-2015-00001
    Event Type
    Death
    Date Received
    January 2, 2015
    Date of Event
    December 22, 2014
    Report Date
    January 2, 2015
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED FROM BED TO SHOWER BY 2 CNAS USING AN EZ WAY LIFT. THE RESIDENT LEANED AND SHIFTED HER WAY FORWARD CAUSING HER TO FALL OUT OF THE SLING AND ONTO HER HEAD FROM AN ELEVATED POSITION. THE RESIDENT WAS TAKEN TO THE HOSPITAL AND PASSED AWAY. AN EZ WAY REPRESENTATIVE INSPECTED THE LIFT AND SLING, WHICH WERE BOTH IN GOOD CONDITION. FACILITY STAFF RECREATED THE SCENE, AND THE SLING APPEARED TO HAVE BEEN HOOKED UP PROPERLY. THE RESIDENT HAD PREVIOUSLY BEEN TRANSFERRED WITH THE EZ LIFT MULTIPLE TIMES PER DAY OVER THE PAST YEAR. THE LIFT AND SLING FUNCTIONED PROPERLY. THE INCIDENT OCCURRED DUE TO THE RESIDENT SHIFTING THEIR WEIGHT AND LEANING FORWARD AND OUT OF THE SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394 EZ WAY SMART LIFT EZ LIFT FNG EZ WAY, INC. L500PN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death