BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 4598503 · Received March 4, 2015

    Report

    Report Number
    4598503
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 4, 2015
    Manufacturer
    TOLLOS, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LIFT WAS BEING LOWERED TO ATTACH TO PATIENT SLING, LIFT FELL OUT OF THE CEILING TRACK. THE LIFT WAS OVER THE TOP OF THE PATIENT BUT WAS CAUGHT BY NURSE AND CNA.FEEDBACK FROM MANAGEMENT PERSONNEL: THE PATIENT TROLLEY LIFT ASSEMBLY CAME OFF THE TRACK AND BARELY MISSED A PATIENT. THE PATIENT WAS MOVED TO ANOTHER ROOM AND THE SYSTEM INVESTIGATED TO UNDERSTAND HOW THIS COULD HAPPEN.I PARTICIPATED IN THE INVESTIGATION AND WE WERE ABLE TO REPLICATE THE PROBLEM. IT APPEARS TO BE AN ENGINEERING FLAW. SPECIFICALLY, THE GATE SYSTEM THAT KEEPS THE TROLLEY ON THE MOVABLE TRACK WHEN IT IS DISENGAGED FROM THE STATIONARY TRACK IS NOT FITTED WITH A FEEDBACK MECHANISM THAT ENSURES THE GATE IS CLOSED BEFORE THE MOVABLE TRACK CAN BE MOVED. AS SUCH, THE GATE CAN BE HELD OPEN AND ALLOW THE TROLLEY, ONCE THE MOVABLE TRACK IS MOVED AWAY FROM THE STATIONARY ONE, TO COME OFF THE TRACK AND FALL TO THE FLOOR. ACCORDINGLY, THE LIFTS HAVE BEEN TAKEN OUT OF SERVICE. FEEDBACK FROM VENDOR TO MANAGEMENT PERSONNEL: WE MET WITH TOLLOS ONSITE TO REVIEW THE FIX PROPOSED BY TOLLOS TO PREVENT THE LIFT FROM COMING OFF OF THE RAIL IF THE SAFETY LATCH IS NOT FULLY ENGAGED. WHAT THEY ARE PROPOSING IS TO MACHINE THE TROLLEY PLATE WHICH CONNECTS THE LIFT MOTOR TO THE OVERHEAD RAILS WITH A SERIES OF SLOTS TO CREATE A RATCHET EFFECT WHICH WOULD CATCH THE GATE LEVER ARM IN THE TROLLEY TO PREVENT THE LIFT FROM MOVING OFF OF THE RAIL. TOLLOS HAS THE MOCK UP RAIL SYSTEM AND GATE THAT WAS USED FOR THIS PROJECT IN THEIR SHOP TO TEST THE FIX BEFORE IT COMES TO THE SITE. THEY ARE PLANNING ON HAVING THIS RESOLVED AND CORRECTED BY THE END OF THE WEEK FOR ALL PATIENT ROOMS. THE IMPACT TO EACH PATIENT ROOM WOULD BE REMOVING THE LIFT FROM THE RAIL, SWAPPING OUT THE MACHINED TROLLEY PIECE AND RE-INSTALLING THE LIFT ON THE RAIL. WHEN TOLLOS ARRIVES ONSITE THEY WILL DO A MOCK UP IN THE FIELD TO DEMONSTRATE TO ALL HOSPITAL PERSONNEL REQUIRED TO WITNESS THE PROPOSED FIX. ONCE IT HAS BEEN ACCEPTED THEN THE PLAN WOULD BE TO SWAP OUT THE OTHER PATIENT ROOMS THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149458 TOLLOS LIFT, PATIENT, AC-POWERED FSA TOLLOS, INC. 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *