BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOLLOS

    MDR report key: 4867547 · Received June 18, 2015

    Report

    Report Number
    MW5043213
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 18, 2015
    Manufacturer
    T.H.E. MEDICAL BARRIE
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TEAM WAS PREPARING TO GET THE PATIENT OUT OF BED USING THE CEILING LIFT. THE SLING HAD BEEN APPROPRIATELY POSITIONED UNDER THE PATIENT. WHILE THE CEILING LIFT WAS BEING LOWERED INTO POSITION SO THAT THE SLING STRAPS COULD BE ATTACHED, THE LIFT MECHANISM LITERALLY FELL APART - THE METAL NUTS, RINGS AND BOLTS FELL OUT DETACHING THE LIFT BAR. ALL COMPONENTS FELL DOWN UPON THE BED STRIKING THE PATIENT IN THE CHEST. THE ESTIMATED FALL DISTANCE WAS ABOUT 18". THE CNA STANDING AT PATIENT'S RIGHT SIDE AND BROKE THE FALL OF THE COMPONENTS WITH CNA'S HANDS, BUT THAT STILL MADE IMPACT WITH THE PATIENT'S LOWER CHEST/UPPER ABDOMEN (APPROX 3"-4" ABOVE G-TUBE SITE). THE PATIENT REPORTED THEY WERE "FINE". PATIENT'S CHEST AND ABDOMEN WERE EXAMINED IMMEDIATELY BY THE RN. NO REDNESS, TENDERNESS, BRUISING. CHEST AND ABDOMEN TOTALLY MARK AND INJURY FREE. MD EXAMINED THE PATIENT UPON ARRIVAL. NO INJURY AND NO FURTHER WORK-UP ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395804 TOLLOS TOLLOS FNG T.H.E. MEDICAL BARRIE CIRRUS 600LBS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR