BEUDAMED
    FDA Adverse Event Death Summary report: N

    TITAN X BARIATRIC MOBILE LIFT

    MDR report key: 2086821 · Received April 29, 2011

    Report

    Report Number
    9615246-2011-00001
    Event Type
    Death
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 20, 2011
    Manufacturer
    1073849 ONTARIO LFT O/A T.H.E. MEDICAL
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSING HOME PURCHASED T.H.E. MEDICAL'S 1,000 LB TITAN FLOOR LIFT IN (B)(6) 2006. AS DESCRIBED TO THE REPRESENTATIVE OF THE MANUFACTURER WHO VISITED THIS FACILITY SHORTLY AFTER THE ADVERSE EVENT, (B)(6) WAS BEING TRANSFERRED BY ONE CAREGIVER WHEN SHE FELL OUT OF THE SLING ONTO THE FLOOR, INJURED HER HEAD, AND WAS TAKEN TO HOSPITAL WHERE SHE EXPIRED. THE SLING IN QUESTION WAS MANUFACTURED BY ANOTHER MANUFACTURER, (B)(4) (NOT T.H.E. MEDICAL). THE SLING WAS STILL ATTACHED TO THE LIFT AFTER THE FALL. THE LIFT WAS INSPECTED AND WAS IN GOOD WORKING ORDER AND DID NOT CAUSE OR CONTRIBUTE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN X BARIATRIC MOBILE LIFT TITAN FNG 1073849 ONTARIO LFT O/A T.H.E. MEDICAL TITAN FPL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death BRAND NAME: (B)(4) SLING| MODEL# 50020| MFR: (B)(4)| (B)(4)| COMMON DEVICE NAME: HOYER LOW BACK HYGIENE SLING