BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 3251903 · Received July 22, 2013

    Report

    Report Number
    1419652-2013-00203
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 6, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ARJO, MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS PREPARING THE RESIDENT BY PLACING THE SLING UNDER HER AND CONNECTING THE FOUR ATTACH POINTS OF THE SLING. NURSE HAS CHECKED RESIDENT FOR CENTERING IN THE SLING. CHECKED THE SLING HOOKS BY PULLING DOWN ON THEM AND RAISED THE RESIDENT UP TO CLEARING THE BED AND PULLED THE LIFT AWAY WHILE HOLDING THE HANDLE OF THE LIFT. NURSE HAS GRABBED THE HANDLE OF THE HANGER BAR, SET IN THE UPRIGHT POSITION AND PLACED RESIDENT IN THE CHAIR. NURSE TURNED HER BACK AND GRABBED THE HANDLES TO MANEUVER THE LIFT INTO POSITION. RESIDENT THEN TIPPED BACKWARD OUT OF THE SLING HITTING HER HEAD ON THE LIFT. NURSE THEN UNHOOKED THE RESIDENT'S LEGS FROM THE LIFT AND SLING. THE PT SUFFERED A LACERATION TO THE HEAD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340243 OPERA FSA ARJO, MED AB LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR