BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN 1000

    MDR report key: 3599232 · Received January 23, 2014

    Report

    Report Number
    MW5034002
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 21, 2014
    Manufacturer
    T.H.E. MEDICAL / TOLLOS INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE THE BARIATRIC PT WAS BEING LIFTED OFF OF THE BED, THE BOLT APPEARS TO HAVE SHEARED OFF. THE LIFT BAR FELL ONTO THE PT'S CHEST AS THE PT WAS DROPPED BACK ONTO THE BED. NO APPARENT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55022 TITAN 1000 LIFT FSA T.H.E. MEDICAL / TOLLOS INC. TITAN 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR