BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIKING

    MDR report key: 1935376 · Received December 15, 2010

    Report

    Report Number
    8030916-2010-00035
    Event Type
    Death
    Date Received
    December 15, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 19, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SLING USED IN THE ALLEGED INCIDENT WAS RETURNED TO THE MFR FROM THE NURSING HOME. NO DAMAGE OR MFG DEFECTS WERE FOUND. THE LIFT USED IN THE ALLEGED INCIDENT WAS NOT RETURNED TO THE MFR. ACCORDING TO THE USER MANUAL (B)(4), THE CAREGIVER SHOULD: "PLACE THE EDGE OF THE SLING AS FAR IN UNDER THE PATIENT AS POSSIBLE, WITH THE LOWER EDGE LEVEL WITH THE PATIENT'S KNEES. GATHER THE SLING TOGETHER IN A COUPLE OF FOLDS AND LAY IT SO THAT THE CENTRE OF THE SLING CORRESPONDS TO THE POSITION OF THE PATIENT'S SPINE". OUR CONCLUSION FROM THE ROOT CAUSE ANALYSIS INDICATES THAT USER ERROR MAY HAVE LED TO THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT STAFF WERE MOVING THE PATIENT FROM WHEELCHAIR TO BED ON A LIKO LIFT. THEY PLACED THE LOOPS OF THE SLING ONTO THE SLING BAR AND INITIATED THE TRANSFER. THE PATIENT FELL OUT OF THE SLING AND HIT HER HEAD ON THE SIDE RAIL OF THE BED. PATIENT LATER EXPIRED. CAUSE OF DEATH IS UNKNOWN. INFO RECEIVED FROM THE FACILITY INDICATES THAT THE SLING WAS NOT PLACED CORRECT UNDER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING NON-AC POWERED PATIENT LIFT FSA LIKO AB VIKING M

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death