BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ LIFT

    MDR report key: 2992797 · Received February 10, 2013

    Report

    Report Number
    2992797
    Event Type
    Malfunction
    Date Received
    February 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 8, 2013
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING A TRANSFER, THE EZ LIFT MALFUNCTIONED. THE BOLT WHICH LIFTS THE PATIENT VERTICALLY APPEARED TO BREAK IN TWO POSITIONS. THE EZ LIFT SNAPPED AND THE ARM OF THE LIFT FELL TO THE GROUND WITH THE PATIENT STILL IN THE SLING. SHE FELL ON THE LEGS OF THE LIFT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TRANSFER FROM BEDSIDE CHAIR TO BED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58042 EZ LIFT LIFT, PATIENT, TRANSFER FSA EZ WAY, INC. 796 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NOT APPLICABLE.