BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT LIFT

    MDR report key: 3884015 · Received June 13, 2014

    Report

    Report Number
    1417592-2014-00060
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THAT WHILE TRANSFERRING THE RESIDENT WITH THE LIFT, THE SLING DETACHED AND THE RESIDENT FELL. SHE HIT HER HEAD, WAS TAKEN TO THE HOSPITAL AND SUBSEQUENTLY DIED. THE DEVICE WAS EVALUATED AND NO DEFECTS WERE IDENTIFIED. ALL FUNCTIONS OF THE LIFT WORKED PROPERLY WHEN TESTED. ALL BOLTS WERE SECURELY FASTENED, ALL LINKAGE PINS WERE LOCKED IN PLACE, THE CRADLE FUNCTIONED PROPERLY, THE LEG SPREADER MECHANISM FUNCTIONED PROPERLY, AND THE CASTERS ROLLED UNIMPEDED ACROSS THE FLOOR. THERE WERE NO MAJOR SCRATCHES OR DENTS ON ANY SECTION OF THE LIFT. THE ADMINISTRATOR REPORTED THAT A SLING FROM ANOTHER MANUFACTURER WAS BEING USED WITH THE LIFT. IT IS SPECIFICALLY STATED IN THE OWNER'S MANUAL THAT USE OF NON-MEDLINE SLINGS IS UNSAFE AND MAY RESULT IN INJURY TO THE RESIDENT. IT HAS BEEN DETERMINED THAT USER ERROR WAS THE CAUSE OF THE INCIDENT. WE HAVE NO INFORMATION TO SUGGEST THE LIFT CAUSED THE INCIDENT BUT IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE SLING DETACHED FROM THE LIFT AND THE RESIDENT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351338 PATIENT LIFT FSA MEDLINE INDUSTRIES, INC. 400EL12120510

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death