BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STAND

    MDR report key: 3912429 · Received June 27, 2014

    Report

    Report Number
    2183887-2014-00004
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED IN AN EZ STAND WHEN THE TIP OF THE ACTUATOR BROKE. THE RESIDENT FELL, AND SUFFERED 3 FRACTURES AND HIT HIS HEAD. THE PATIENT WAS HOSPITALIZED AND LATER PASSED AWAY. THE EZ STAND WAS 12 YEARS OLD AND HAD NOT BEEN INSPECTED AND MAINTAINED PROPERLY. A REPLACEMENT ACTUATOR WAS ORDERED. AN EZ WAY REPRESENTATIVE STRESSED THE NEED TO PROPERLY INSPECT AND MAINTAIN THE PRODUCT MONTHLY PER THE PREVENTATIVE MAINTENANCE CHECKLIST. A LETTER AND ADDITIONAL PREVENTATIVE MAINTENANCE CHECKLIST WAS ALSO SENT BY THE COMPANY IN APRIL TO ALL EZ STAND OWNERS REMINDING THEM OF THE IMPORTANCE OF PROPERLY MAINTAINING EZ WAY EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376293 EZ STAND SIT TO STAND FNG EZ WAY, INC. 898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death