BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 8974913 · Received September 9, 2019

    Report

    Report Number
    8974913
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    January 9, 2019
    Report Date
    August 21, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE CASE, THE PROPOFOL PUMP STOPPED WORKING. IT ASKED FOR A CODE TO RESET IT, AND WE WERE NOT ABLE TO OBTAIN THE CODE FROM ANYONE WE CONTACTED. AN ANESTHESIA LICENSED PRACTICAL NURSE (LPN) BROUGHT A PROPOFOL PUMP FROM ANOTHER ROOM, SO THERE WAS NO DISRUPTION IN CARE. COMPANY NAME: SMITHS MEDICAL MD INC. MODEL #MEDFUSION 4000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769123 MEDFUSION PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA