BEUDAMED
    FDA Adverse Event Other Summary report: N

    SABINA II

    MDR report key: 665041 · Received January 11, 2006

    Report

    Report Number
    1225750-2005-00023
    Event Type
    Other
    Date Received
    January 11, 2006
    Date of Event
    November 30, 2005
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2005, A PT FELL WHILE BEING RAISED IN A SABINA II PATIENT LIFT/HOIST. ACCORDING TO THE FACILITY, THE RESIDENT WAS BEING LIFTED FROM SEATED POSITION WHEN THE LEFT CAME DOWN QUICKLY ON ITS OWN AND THE RESIDENT SLIPPED OUT OF THE SLING AND FELL TO THE GROUND. THE PT WAS EXAMINED AND WAS FOUND TO HAVE A BROKEN KNEE CAP AND HURT SHOULDER. THE EQUIPMENT WAS TAKEN OUT OF SERVICE AND WILL BE RETURNED TO LIKO INC FOR ANALYSIS.

    Description of Event or Problem · 1

    IN FEBRUARY 2006 LIFT WAS LOAD TESTED AT LIKO INC AND NO FAULT WAS FOUND. INCIDENT AS DESCRIBED BY THE FACILITY COULD NOT BE DUPLICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other