BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER ELEVATE LIFT

    MDR report key: 22912220 · Received August 28, 2025

    Report

    Report Number
    3009402404-2025-00036
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Report Date
    August 27, 2025
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    UDI-DI
    00810055880096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT RESIDENT WAS BEING MOVED FROM TOILET TO WHEELCHAIR VIA JOERNS SIT TO STAND DEVICE. DURING THE TRANSFER THE SIT STAND DEVICE FAILED CAUSING THE RESIDENT AND HER LNA TO END UP ON THE FLOOR. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520464 HOYER ELEVATE LIFT PATIENT LIFT FSA APEX HEALTHCARE MFG. INC HOY-ELEVATEWSC 00810055880096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other