BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PC% CABINET MOUNT FLOWMETER

    MDR report key: 14805524 · Received June 24, 2022

    Report

    Report Number
    2020813-2022-00004
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTRA PC% CABINET MOUNT FLOWMETER WAS RETURNED TO ACCUTRON FOR EVALUATION AND WAS FOUND TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED AND THE UNIT WAS RETURNED TO THE USER FACILITY. THE ULTRA PC% CABINET MOUNT FLOWMETER INSTRUCTIONS FOR USE STATES, "TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE. PATIENT SHOULD ALWAYS BE CLOSELY MONITORED DURING NITROUS OXIDE USE. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED. THE O2 FLUSH BUTTON CAN BE USED TO RAPIDLY PURGE THE LINES OF N2O." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING TWO SEPARATE PATIENT PROCEDURES INVOLVING THE ULTRA PC% CABINET MOUNT FLOWMETER, THE PATIENTS BECAME SICK AND BEGAN TO VOMIT. BOTH OF THE PATIENTS RECOVERED QUICKLY WITHOUT ADDITIONAL MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072871 ULTRA PC% CABINET MOUNT FLOWMETER FLOWMETER BSZ ACCUTRON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown