BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNO 102

    MDR report key: 756225 · Received August 28, 2006

    Report

    Report Number
    1225750-2006-00017
    Event Type
    Death
    Date Received
    August 28, 2006
    Date of Event
    December 5, 2005
    Report Date
    July 31, 2006
    Manufacturer
    LIKO, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 24, 2006, A SIMILAR PATIENT LIFT WAS EVALUATED AT LIKO INC CORPORATE OFFICE. THE REPORTED INCIDENT COULD NOT BE REPLICATED WHEN THE SLING AND LIFT WERE OPERATED PER MANUFACTURE INSTRUCTIONS. ON GOING INVESTIGATION, FOLLOW UP REPORT WILL BE FORWARDED.

    Description of Event or Problem · 1

    IN 2005, FACILITY REPORTED THAT A RESIDENT FELL WHILE BEING TRANSFERRED FROM BED TO CHAIR USING AN UNO 102 PATIENT LIFT. ACCORDING TO THE FACILITY, THE RESIDENT SUDDENLY HYPER FIXED BOTH KNEES AND DREW UP LEGS BACKWARDS BUTTOCKS. RESIDENT'S BODY SHIFTED AND ROLLED TO THE LEFT. THIS CAUSED THE LEFT ARM OF THE CROSSBAR TO DIP DOWNWARD RESULTING IN THE HINGED SAFTEY CLIP TO DROP BACKWARD WHICH ALLOWED THE LOOP OF THE LEFT SHOULDER STRAP ON SLING TO BECOME UNHOOKED ON THE CROSSBAR. RESIDENT ROLLED OUT OF SLING FALLING ONTO HER BACK, BUTTOCKS AND POSTERIOR. RESIDENT WAS ASSESSED AT LOCAL EMERGENCY ROOM. CONFIRMED SUBDURAL HEMATOMA. RESIDENT WAS RETURNED TO FACILITY SAME DAY. POA WISHED FOR NO TREATMENT TO PROLONG LIFE. RESIDENT EXPIRED AT 5PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO 102 PATIENT LIFT/HOIST FSA LIKO, INC. UNO 102EM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death