BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 18194600 · Received November 22, 2023

    Report

    Report Number
    3009402404-2023-00040
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Report Date
    November 16, 2023
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY (B)(6) HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY(B)(6) 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 HAD INCIDENT WITH 3 CAREGIVERS MOVING ONE RESIDENT, CLAIM IT TIPPED AS THERE WERE ONLY 2 CONNECTION POINTS HAVE HAD ISSUES IN THE PAST AND WERE CITED FOR THESE ISSUES THIS IS WHY THEY ARE RENTING MULTIPLE LIFTS THEY WERE NOT TRAINED BY A JHC REP, HAD THEIR INTERNAL THERAPY TEAM CONDUCT TRAINING. COMPLAINT (B)(4) AND RA #(B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE LIFT RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE LIFT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620987 HOYER LIFT PATIENT LIFT FSA APEX HEALTHCARE MFG. INC HOY-PRESENCE-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other