BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXILIFT

    MDR report key: 1061384 · Received June 16, 2008

    Report

    Report Number
    9617021-2008-00020
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE STAFF MEMBER WAS TRANSFERRING THE RESIDENT WHEN THE RESIDENT BECAME STIFF AT THE HIP AND KNEE. HER KNEE WAS FULLY EXTENDED, WHICH APPARENTLY CAUSED HER LEG TO COME UP UNDER THE LEG CLIP. THE CLIP DETACHED FROM THE LIFT. THERE WERE NO HEAD STAYS IN THE SLING, AND THE RESIDENT CAME OUT OF THE LIFT SLING AND HIT HER HEAD ON THE FLOOR. THE STAFF MEMBER THAT WAS BEHIND THE LIFT THEN DETACHED THE SHOULDER CLIP TO FULLY DISENGAGE THE RESIDENT FROM THE LIFT. THE RESIDENT SUSTAINED A LACERATION TO THE HEAD (BACK, MIDDLE), WHICH REQUIRED THREE STAPLES TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT PATIENT LIFT FNG ARJO MED AB LTD. KMBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention