BEUDAMED
    FDA Adverse Event Injury Summary report: N

    400 LB SMART STAND

    MDR report key: 23113097 · Received September 22, 2025

    Report

    Report Number
    2183887-2025-00004
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 22, 2025
    Manufacturer
    EZ WAY INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CNA WAS HOOKING THE RESIDENT UP TO STAND. SHE STOOD UP THE RESIDENT IN THE STAND AND TRIED TO PULL IT BACK, BUT THE STAND WAS STUCK. THE WHEELS WOULD NOT ROLL BACK. SHE HAD TO PUSH THE STAND FORWARD AND PULL IT BACK AGAIN. AT THIS POINT, THE RESIDENT WAS NOT OVER WHEELCHAIR AND THE STAND ARM LOWERED DOWN ON ITS OWN. THE RESIDENT WAS TOO LOW TO PUT BACK IN THE WHEELCHAIR, SO 3 STAFF HAD TO DISCONNECT HER FROM THE STAND AND LOWER HER TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594558 400 LB SMART STAND STAND FSA EZ WAY INC S400PN-03

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention