BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DC FLOWMETER

    MDR report key: 22748705 · Received August 8, 2025

    Report

    Report Number
    2020813-2025-00005
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830021219
    PMA / PMN Number
    K970163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE AND THOROUGH TEST AND EVALUATION WAS CONDUCTED OF THIS FLOWMETER. COULD NOT DUPLICATE REPORTED PROBLEM. FLOWMETER MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED THAT THE UNIT IS GIVING TOO MUCH NITROUS AND MAKING PATIENTS SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193191 ULTRA DC FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 31980 00813830021219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other