BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ LIFT

    MDR report key: 704753 · Received April 25, 2006

    Report

    Report Number
    2183887-2006-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2006
    Date of Event
    March 27, 2006
    Report Date
    April 24, 2006
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS BEING TRANSFERRED WITH A LIFT WHEN THE ACTUATOR FAILED IN THE AREA WHERE THE OUTER TUBE ATTACHES TO THE MOTOR, CAUSING A PATIENTTO DROP TO THE FLOOR. THE PATIENT ADMITTED TO THE HOSPITAL FOR ABSERVATION, AND WAS NOT HURT. EZ WAY'S STAFF WENT TO THE FACILITY TO INSPECT THE ACTUATOR, AND FOUND THAT THE FLANGE ATTACHMENT POINT TO THE GEAR BOX CAUSING THE LEAD SCREQ TO FAIL. SKF/MAGNETIC, THE MANUFACTURER OF THE ACTUATOR WAS CONTACTED AND STATED THAT THE ACTUATOR FAILURE WAS LIKELY DUE TO THE PLACEMENT OF A SIDE-LOAD ON THE ACTUATOR, AND THAT COMBINED WITH WEAR OVER TIME MAY HAVE CASUED THE FAILURE. THE FACILITY HAS NOT YET RELEASED THE ACTUATOR FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ LIFT EZ LIFT FSA EZ WAY, INC. 798 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization