BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPO LIFT

    MDR report key: 511937 · Received February 18, 2004

    Report

    Report Number
    9617021-2004-00015
    Event Type
    Death
    Date Received
    February 18, 2004
    Date of Event
    November 23, 2003
    Report Date
    February 18, 2004
    Manufacturer
    ARJO, LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS TWO CAREGIVERS WENT INTO THE RESIDENT'S ROOM TO GET PT UP FOR SUPPER. THE SLING WAS POSITIONED WITH THE HEAD WHERE IT WAS SUPPOSED TO BE AND WITH THE TWO LEG STRAPS BETWEEN THEIR LEGS. THEY THEN BROUGHT THE LIFTER OVER THE RESIDENT, HOOKED ALL THE CLIPS TO THE LIFTER, AND BEGAN RAISING THE RESIDENT OFF THE BED. THE CAREGIVERS PUSHED DOWN ON THE HANDLE TO MOVE THE RESIDENT TO A SEATED POSITION. ONE CAREGIVER BEGAN MOVING THE LIFT AWAY FROM THE BED WHILE THE OTHER HELD THE RESIDENT'S FEET AS THEY WERE MOVED AROUND THE SIDE OF THE BED CLOSEST TO THE DOOR. THE LEFT LEG CLIP DETACHED AND THE RESIDENT SLIPPED BACKWARDS OUT OF THE SLING ONTO THE FLOOR ON THEIR BACK AND BOTTOM. ALL THE OTHER CLIPS STAYED HOOKED. THE RESIDENT SUFFERED A 12 CM SKIN TEAR TO THEIR LEFT LEG. THE TEAR WAS BANDAGED AND THE RESIDENT WAS PUT INTO THEIR WHEELCHAIR AND PUSHED OUT TO THE LOBBY TO WAIT FOR SUPPER. ABOUT THIRTY MINUTES LATER, THE RESIDENT WAS TAKEN BACK TO THEIR ROOM AND PLACED BACK IN THEIR BED, WHERE THEY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO LIFT PT LIFT FSA ARJO, LTD. KPBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death