BEUDAMED
    FDA Adverse Event Other Summary report: N

    SABINA

    MDR report key: 850222 · Received April 30, 2007

    Report

    Report Number
    1225750-2007-00011
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    April 19, 2007
    Report Date
    April 30, 2007
    Manufacturer
    LIKO, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 25, 2007, A DISTRIBUTOR WAS ALLOWED TO VIEW AND INSPECT THE EQUIPMENT. THE PT LIFT WAS FOUND TO BE IN VERY GOOD WORKING ORDER AND HAD NOT BEEN REMOVED FROM SERVICE AT THE FACILITY. THE CLINICAL EDUCATION NURSE (CEN) BELIEVES THAT THE CAREGIVER DID NOT USE THE SAFETY VEST CORRECTLY AND THAT A MEDIUM SIZED SAFETY VEST SHOULD HAVE BEEN USED FOR THIS PT NOT THE LARGE SIZE VEST AS WAS USED IN THE INCIDENT. THE INCIDENT COULD NOT BE RECREATED BY FACILITY WHEN THE VEST AND PT LIFT WERE USED CORRECTLY PER MFR'S INSTRUCTIONS. FACILITY OFFERED REMEDIAL TRAINING ON THE USE OF THIS EQUIPMENT TO THE STAFF.

    Description of Event or Problem · 1

    FACILITY REPORTS THAT WHILE TRANSFERRING A PT FROM BATHROOM TO BED, USING A SABINA II PT LIFT, WITH A LARGE SIZE SAFETY VEST, THAT THE PT SLIPPED OUT OF THE VEST STRIKING THE BACK OF HER HEAD ON THE FLOOR. PT SUFFERED A SMALL HEMATOMA AND BRUISING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other