BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROMEDIC

    MDR report key: 3040518 · Received March 15, 2013

    Report

    Report Number
    3005536958-2013-00002
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 15, 2013
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSES WERE TRANSFERRING RESIDENT FROM BED TO CHAIR USING A EVA 450EE LIFT AND SMALL HIGHBACK SLING. NURSES LIFTED LEGS OF RESIDENT OFF BED WHILE RESIDENT WAS BEING LIFTED. THE SLING LOOP CAME OFF THE SLING BAR CAUSING THE RESIDENT TO FALL TO THE FLOOR. RESIDENT RECEIVED SKIN TEARS ON BOTH THE RIGHT AND LEFT ELBOWS AS A RESULT. FACILITY MAINTENANCE AND HANDICARE REP BOTH INSPECTED THE LIFT AND SLING AND FOUND BOTH TO BE IN GOOD WORKING ORDER. NURSES WERE UNABLE TO REPLICATE HOW THE INCIDENT OCCURRED AND WERE RETRAINED ON USING LIFT AND PROPER SLING APPLICATION. INCIDENT WAS DEEMED USER ERROR DUE TO IMPROPER SECURING OF SLING LOOPS CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110066 ROMEDIC EVA 450EE PATIENT LIFT FSA HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other