BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOERNS HEALTHCARE

    MDR report key: 8561664 · Received April 26, 2019

    Report

    Report Number
    8561664
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    March 28, 2019
    Report Date
    March 28, 2019
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BRACKET OF HOYER #1880 DETACHED FROM ARM OF SLING WHILE RESIDENT WAS ATTACHED AND IN POSITION TO BE LIFTED FROM THE BED. BARELY OFF THE BED WHEN EQUIPMENT FAILED AND DETACHED. BRACKET LANDED AROUND THE RESIDENT WITHOUT SUSTAINING ANY INJURIES AND THE RESIDENT REMAINED FLAT ON THE BED. APPEARS AS IF THE PIN TO THE MAIN BOLT WAS NO LONGER IN PLACE. ALL OTHER HOYERS IMMEDIATELY REMOVED FROM OPERATION FOLLOWING THIS INCIDENT FOR SAFETY INSPECTION. INSPECTED AND TESTED BEFORE BEING RETURNED TO THE UNITS FOR RESIDENT/STAFF USE. ON 04/01/2019 HOYER REP: "HEARD OF IT BUT NOT OF PIN FALLING OUT: SENDING NEW LOCKNUT FOR ALL NEW HOYERS, REPLACING (1) SCALE FOR FREE." LAST "PM" PERFORMED AT FACILITY ON EQUIPMENT: 03/05/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351188 JOERNS HEALTHCARE HOYER LIFT FSA JOERNS HEALTHCARE HPL - 402

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention