BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ WAY

    MDR report key: 6950590 · Received October 15, 2017

    Report

    Report Number
    2183887-2017-00003
    Event Type
    Death
    Date Received
    October 15, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION PROVIDED BY THE USER FACILITY THIS WAS OPERATOR ERROR. WHEN THE STAFF MEMBERS RAN THE LIFT INTO THE CHAIR THIS CAUSED THE RESIDENT TO BE EJECTED. ALL DEVICES WERE CHECKED OUT AND WERE IN GOOD WORKING ORDER. (B)(4).

    Description of Event or Problem · 1

    TWO STAFF MEMBERS WERE TRANSFERRING A RESIDENT FROM A BED TO A CHAIR WITH A L500PN EZ WAY LIFT WITH A SMALL SLING. ACCORDING TO (B)(6), AFTER LIFTING THE RESIDENT THE TWO STAFF MEMBERS WERE MOVING THE LIFT WITH THE RESIDENT AND STRUCK A CHAIR WITH THE LIFT. THIS RESULTED IN THE RESIDENT BEING EJECTED FROM THE SLING STRIKING HER HEAD IN THE FALL. THIS RESIDENT SUFFERED A 2CM HEMATOMA AS A RESULT. THE RESIDENT WAS TRANSFERRED TO AN ACUTE CARE FACILITY, AND THEN LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730067 EZ WAY LIFT, SMALL SLING FSA EZ WAY, INC. L500PN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death