BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOYER LIFT

    MDR report key: 21368794 · Received February 12, 2025

    Report

    Report Number
    3009402404-2025-00008
    Event Type
    Death
    Date Received
    February 12, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 12, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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 USER, THAT CUSTOMER STATES WHILE USING THE HPL700-S2 LIFT THERE WAS SLACK IN THE LOOPS. ALLEGEDLY, THIS LIFT DOES NOT HAVE SAFETY CLIPS. THE STAFF DID NOT ENSURE THE LOOPS WERE ALL THE WAY ON THE SIDE. PATIENT FELL OFF THE LIFT ON THEIR HEAD. THEY WERE HOSPITALIZED AND BROKE THEIR NECK. CUSTOMER REPORTS THAT THE PATIENT WAS IN THE HOSPITAL AND RELEASED. A DAY AFTER RELEASE, THE PATIENT PASSED AWAY. THE FOLLOWING INJURIES ALLEGEDLY OCCURRED: PATIENT BROKE THEIR NECK. REPORTER REPORTED THAT THE INJURED PARTY WAS TREATED AT A HOSPITAL/CLINIC AND RELEASED. THE PRODUCT HAS BEEN TAKEN OUT OF USE. THE RESIDENT'S WEIGHT IS 177.5 LBS. 2 OTHER PEOPLE, AIDS, WERE PRESENT DURING THE INCIDENT. WHEN ASKED ABOUT AN IDEAL OUTCOME, FACILITY WANTS HOYER TO BE ADVISED ABOUT THIS ISSUE WITH NO SAFETY CLIPS. FOLLOW UP NEEDS TO TAKE PLACE WITHIN 24 HOURS. JOERNS IS NOT AWARE OF THE SLING THE CUSTOMER WAS USING AND HAS REQUESTED THAT INFORMATION. NO RESPONSE HAS BEEN GIVEN BY THE CUSTOMER. COMPLAINT # (B)(4) AND RA# (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE PRODUCTS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE PRODUCTS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965799 HOYER LIFT PATIENT LIFT FSA JOERNS HEALTHCARE HPL700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death