BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFT

    MDR report key: 22579420 · Received July 23, 2025

    Report

    Report Number
    3009402404-2025-00025
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Report Date
    July 17, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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, PER THE END USER, THAT THE MD AT CORVALLIS MANOR. IT WAS DETERMINED THE FALL THAT TOOK PLACE WAS HUMAN ERROR. ONE OF THE STRAPS OF THE SLING BECAME DETACHED, CAUSING THE PT TO FALL. THE LIFT AND SLING WAS TAKEN OFF THE FLOOR PENDING INSPECTION OF EQUIPMENT. IT WAS DETERMINED THE HOYER WAS IN GOOD WORKING ORDER. THE SN OR PART NUMBER OF THE SPECIFIC LIFT WAS UNOBTAINABLE FROM THE FACILITY. THEY WILL NOT RESPOND. IT WAS A MEDLINE SLING THAT WAS BEING USED WITH A JOERNS LIFT. COMPLAINT#: (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47138 LIFT PATIENT LIFT FSA JOERNS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown