BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNO

    MDR report key: 1211107 · Received October 24, 2008

    Report

    Report Number
    3006252983-2008-00040
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 1, 2008
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PURSUANT TO IDENTIFYING A REPORTABLE EVENT INVOLVING UNO 102 PATIENT LIFT, LIKO HAS PERFORMED A RETROSPECTIVE REVIEW ON SIMILAR EVENTS TO DETERMINE REPORTABILITY. THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    FACILITY REPORTS THAT IN 2008, A RESIDENT WAS ABOUT TO BE POSITIONED ONTO THE BED USING AN UNO 102EE MOBILE LIFT, WHEN WITHOUT PRECURSOR SOUNDS, THERE WAS A SUDDEN SNAP OF THE LIFTING MECHANISM AND THE RESIDENT IMMEDIATELY FELL TO THE FLOOR AT ESTIMATED DISTANCE OF 3 - 4 FEET MEASURED FROM HIS BUTTOCKS. THE POINT OF IMPACT WAS THE RESIDENT'S HIP AND BUTT. THE RESIDENT DID NOT HIT HIS HEAD IN THE FALL. THE RESIDENT WAS EXAMINED BY THREE REGISTERED STAFF AND TRANSFERRED TO HOSPITAL WHERE HE LATER DIED OF CAUSES YET NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO AC POWERED PT LIFT FSA LIKO AB UNO 102EE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death