BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY SIT TO STAND LIFTING DEVICE

    MDR report key: 4059580 · Received August 29, 2014

    Report

    Report Number
    MW5038033
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A WEAR POINT ON THE ACTUATOR OF AN EZ MECHANICAL LIFT FAILED, AND THE LIFT MALFUNCTION CAUSED THE RESIDENT TO ABRUPTLY SET BACK ON HER MATTRESS. SHE SUFFERED NO INJURY, AND VERBALIZED NO FEELINGS OF PAIN OR DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528174 EZ WAY SIT TO STAND LIFTING DEVICE PATIENT LIFT FSA EZ WAY, INC. 898

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR