BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY SMART LIFT

    MDR report key: 6949101 · Received October 3, 2017

    Report

    Report Number
    6949101
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 2, 2017
    Manufacturer
    EZ WAY INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO HST'S (CNA'S) ASSISTING RESIDENT WITH A TRANSFER FROM CHAIR INTO BED USING AN EZ WAY SMART LIFT. ALL 4 LOOPS OF THE SLING WERE ATTACHED TO THE HOOKS ON THE LIFT. ONE HST BEGAN RAISING THE LIFT AND THE OTHER HST REMOVED CHAIR FROM UNDER RESIDENT AS RESIDENT WAS BEING LIFTED OUT OF THE CHAIR. TOP RIGHT LOOP OF SLING CAME OFF OF THE HOOK ON THE LIFT AND RESIDENT FELL TO THE FLOOR. THE SLING USED IN THE INCIDENT IS IN EXCELLENT CONDITION. THE RESIDENT HAD A SMALL ABRASION TO THE BACK OF THE HEAD. THE RESIDENT HAS REMAINED AT HER BASELINE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692776 EZ WAY SMART LIFT SMART LIFT FSA EZ WAY INC. 598

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR