BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWMETER, DIGITAL FLEXMOUNT

    MDR report key: 20055743 · Received August 23, 2024

    Report

    Report Number
    2020813-2024-00002
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED WITH SOME COSMETIC DAMAGE. INITIAL TESTING CONFIRMED REPORTED PROBLEM: NITROUS OXIDE FLOW HIGHER THEN IT IS SET FOR. WHEN NITROUS OXIDE IS EXPECTED TO BE 2 LPM, ACTUAL FLOW GOES TO ABOUT 14 LPM, WHICH IS ALREADY MAXIMUM POSSIBLE FLOW FOR NITROUS OXIDE. CAUSE COULD NOT BE DETERMINED AT THIS TIME. THIS MODEL WAS DISCONTINUED IN 2010.

    Description of Event or Problem · 0

    USER REPORTED MULTIPLE PATIENTS FEELING ILL EFFECTS WHEN USING THIS FLOWMETER FOR NITROUS OXIDE. THE FLOWMETER SHOWED OXYGEN 3 LPM, NITROUS OXIDE 0%, METER READ BETWEEN 3-4 LPM OUTPUT. CHANGED THE GAS MIX TO 50% OXYGEN / 50% NITROUS OXIDE WHILE MAINTAINING 3 LPM ON THE FLOWMETER, BUT THE ACTUAL OUTPUT VOLUME JUMPED AND FLUCTUATED BETWEEN 8-15+ LPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618647 FLOWMETER, DIGITAL FLEXMOUNT FLOWMETER BSZ ACCUTRON, INC. 26289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other