BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER ADVANCE-E LIFT

    MDR report key: 25281082 · Received May 26, 2026

    Report

    Report Number
    3009402404-2026-00011
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 22, 2026
    Manufacturer
    APEX HEALTH CARE MFG., INC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    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: WIFE WAS TRANSFERRING HUSBAND FROM BED TO WHEELCHAIR. HAS PREVIOUS EXPERIENCE WITH LIFTING PROCESS BUT FIRST EXPERIENCE WITH HOYER BRAND LIFT. PLACED SLING UNDER PATIENT WHILE IN THE BED. U-SLING STYLE BUT DOES NOT KNOW IF HOYER BRAND. PUSHED BUTTON TO RAISE LIFT AND SHE TURNED HIS BODY TO HAVE LEGS OVER THE SIDE OF FRAME. LIFT WAS FULLY CHARGED OVERNIGHT. AS LEGS WERE BEING TURNED, SHE FELT HUSBAND WAS NOT AS HIGH AS NORMAL WHEN USING PREVIOUS LIFT. CONTINUED TRANSFER AND DURING SWING TO WHEELCHAIR, RESIDENT WAS LOWERING WITHOUT A BUTTON PUSH AND THEN REALIZED LIFT WAS TILTING AND SHE IMMEDIATELY STARTED PUSHING DOWN BUTTON. WITHIN SECONDS HUSBAND WAS ON FLOOR AND LIFT WAS OVER HIM. MAST WAS COMPLETELY BENT AT MAST TIGHTENING KNOB. NO INJURY OCCURRED AT TIME OTHER THAN DISTRESS OF INCIDENT AND UNSCREWING THE MAST TIGHTENING KNOB TO ALLOW MOVEMENT OF THE LIFT FROM OVER HUSBAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333914 HOYER ADVANCE-E LIFT PATIENT LIFT FSA APEX HEALTH CARE MFG., INC HOY-ADVANCE-E

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male