BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ WAY

    MDR report key: 17604729 · Received August 23, 2023

    Report

    Report Number
    2183887-2023-00002
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    June 18, 2023
    Report Date
    August 22, 2023
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LINDSEY HUGHES, PATIENT SAFETY SPECIALIST, CONFIRMED THE UNIT USED DURING THIS INCIDENT WAS PLACED BACK IN SERVICE AFTER THIS INCIDENT. OPERATOR'S INSTRUCTIONS FOR THE EQUIPMENT USED IN THIS INCIDENT STATES, "AS PATIENTS DO VARY IN SIZE, SHAPE, WEIGHT AND TEMPERAMENT, THESE CONDITIONS MUST BE TAKEN INTO CONSIDERATION WHEN DECIDING IF THE EZ WAY SMART STAND IS SUITABLE FOR THEIR NEEDS. PATIENTS SHOULD BE ABLE TO BEAR SOME WEIGHT, HAVE UPPER BODY STRENGTH AND BE ABLE TO FOLLOW SIMPLE COMMANDS. IF A PATIENT DOES NOT MEET EACH OF THESE THREE CRITERIA, AN EZ WAY TOTAL BODY LIFT MUST BE USED. HEALTH EFFECT - CLINICAL CODE HAS NOT BEEN PROVIDED BY THE END USER.

    Description of Event or Problem · 0

    PATIENT WAS BEING TRANSFERRED FROM A CHAIR TO A BED WHEN TEH PATIENT'S LEGS WEAKENED AND BUCKLED CAUSING THE PATIENT'S ARMS TO FALL INTO THE SLING OF THE STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263642 EZ WAY PREMIER STAND FSA EZ WAY, INC. 8002

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other| H| R