BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAULIC LIFT

    MDR report key: 23045743 · Received September 12, 2025

    Report

    Report Number
    3009402404-2025-00044
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 12, 2025
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION 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 USRESIDENT WAS IN WHEELCHAIR, LIFTED RESIDENT OUT OF CHAIR, WHEN THEY WENT TO CLOSE LEG TO MANEUVER LIFT LEFT LEG SNAPPED, RESULTING IN A FALL. CNA REPORTS THAT SHE INSPECTED LIFT JUST PRIOR TO USE AND DID NOT NOTICE ANY UNUSUAL WEAR OR STRESS ON UNIT. THE UNIT IS OVER 14 YEARS OLD. JOERNS HAS ENTERED COMPLAINT #(B)(4) INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287639 HYDRAULIC LIFT PATIENT LIFT FSA APEX HEALTHCARE MFG. INC C-HLA-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other