BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 3367608 · Received September 18, 2013

    Report

    Report Number
    3367608
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    September 7, 2013
    Report Date
    September 18, 2013
    Manufacturer
    TOLLOS, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE PATIENT LIFT IN THE MORGUE, STAFF MEMBER RETRACTED THE LIFT AND PUSHED IT OUT OF THE WAY SO THAT THE TOP OF THE MORGUE CART COULD BE PUT BACK IN PLACE. AS NURSE PUSHED THE LIFT OUT OF THE WAY, THE LIFT MOTOR FELL OFF OF THE TRACK AND LANDED ON HER CHEST AND ON HER HAND, CAUSING NURSE TO FALL TO THE GROUND. NURSE HAD MINOR CUTS ON HER HAND AND STATED THAT HER CHEST HURT AND COULDN'T BREATHE. SECURITY OFFICER CONTACTED THE ED AND HAD STAFF RESPOND WITH A WHEEL CHAIR TO THE MORGUE. NURSE/EMPLOYEE WAS LOADED ONTO THE WHEEL CHAIR AND TAKEN TO THE ED FOR TREATMENT. AFTER INVESTIGATING THE LIFT DEVICE, IT WAS NOTICED THAT THE PIN THAT IS SUPPOSE TO STOP THE MOTOR FROM FALLING OFF THE RAIL WAS MISSING AND WAS LAYING ON THE TABLE NEXT TO THE MAIN DOOR OF THE MORGUE. THERE WAS ALSO A CAP THAT WAS MISSING THAT GOES ON THE END OF THE RAILING. THERE WAS NO REACTION TIME FOR THE EMPLOYEE TO GET OUT OF THE WAY DUE TO THE WEIGHT OF THE MOTOR AS WELL AS NOT KNOWING THAT VITAL PIECES OF THE RAILING WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469781 TOLLOS LIFT, PATIENT, AC-POWERED FNG TOLLOS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *