BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNO

    MDR report key: 2071611 · Received April 13, 2011

    Report

    Report Number
    8030916-2011-00021
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 14, 2011
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT WAS TESTED AND FOUND TO OPERATE CORRECTLY. THE SLING BAR WAS MISSING THE SAFETY LATCHES AT THE TIME OF THE EVENT, BUT THEY HAVE SINCE BEEN REPLACED. ACCOUNT STATED THEY PLAN TO CONTINUE USE OF THE LIFT AS THEY FEEL THE PROBLEM IS DIRECTLY RELATED TO ACTIONS OF THE PT. INSTRUCTION GUIDE 7EN150104-02 FOR THIS LIFT STATES: NEVER LEAVE A PT UNATTENDED IN A LIFTING SITUATION.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT WHILE THE PT WAS IN THE SLING, THE ATTENDANT LEFT THE SIDE OF THE PT BRIEFLY. WHEN THE ATTENDANT WALKED AWAY, THE PT BEGAN KICKING AND CONTINUED TO INCREASE THE AMOUNT OF KICKING UNTIL SHE FLIPPED AND HIT HER HEAD. ACCOUNT STATED AT THE TIME OF THE INCIDENT, THERE WAS ONLY ONE ATTENDANT AVAILABLE. THE LIFT REMAINED IN NORMAL OPERATIONAL POSITION AND THE SLING WAS STILL ATTACHED TO THE SLING BAR. ACCOUNT STATED THE PT WAS TREATED AND RECEIVED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO NON-AC POWERED PATIENT LIFT FSA LIKO AB UNO 100 EE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other