BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOYER LIFTS

    MDR report key: 18945891 · Received March 20, 2024

    Report

    Report Number
    3009402404-2024-00009
    Event Type
    Death
    Date Received
    March 20, 2024
    Report Date
    March 16, 2024
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND 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 FACILITY CALLED IN STATING THAT STAFF DROPPED A RESIDENT FROM A HPL700 AND SUFFERED BROKEN BONES, PASSING LATER. FACILITY MENTIONED THAT THEY PURCHASED A HOYER PRESENCE CRADLE AND INSTALLED IT ON THE LIFT, WHICH FAILED. MULTIPLE ATTEMPTS HAVE HAPPENED TO REACH OUT TO THE CUSTOMER TO GET MORE INFORMATION ON THE DETAILS AND THE LIFT DETAILS, BUT NO CUSTOMER RESPONSE. COMPLAINT #1398218 WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523887 HOYER LIFTS PATIENT LIFT FSA JOERNS HEALTHCARE HPL700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D| H