BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNO

    MDR report key: 694243 · Received March 29, 2006

    Report

    Report Number
    1225750-2006-00004
    Event Type
    Other
    Date Received
    March 29, 2006
    Date of Event
    March 19, 2006
    Report Date
    March 29, 2006
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON MARCH 19, 2006 WHILE TRANSFERRING A RESIDENT USING AN UNO 102 PT LIFT, THE FACILITY REPORTED THAT WITH 3 OF THE 4 LIFT STRAPS IN PLACE, THE LIFT ROSE QUICKLY WITHOUT USE IF THE HAND CONTROL. THE RESIDENT FELL OUT OF THE SLING SUFFERING A LACERATION TO THE HEAD. THREE DAYS LATER A LIKO REP. WAS ALLOWED TO VIEW AND INSPECT THE EQUIPMENT. IT WAS FOUND THAT THE SAFETY LATCHES ON THE SLINGBAR WERE MISSING AND THE LIFT DID NOT HAVE APPEARANCE OF BEING PROPERLY MAINTAINED. THE HAND CONTROL IS BEING RETURNED TO LIKO INC FOR ANALYSIS, AND A FOLLOW UP REPORT WILL BE FORWARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO PATIENT LIFT/HOIST FSA LIKO AB UNO 102EE *

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other