BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, CM

    MDR report key: 22882511 · Received August 25, 2025

    Report

    Report Number
    2020813-2025-00008
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830021141
    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. COULD NOT DUPLICATE REPORTED PROBLEM OF TOO MUCH N2O FLOW. UNIT MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    DR. BELIEVES SEDATION LEVELS ARE HIGHER THAN UNIT SHOWS. THIS UNIT WAS PREVIOUSLY REPAIRED AND RETURNED BUT DR. COMPLAINED THAT UNIT IS MAKING PATIENTS SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823502 FLOWMETER, CM FLOWMETER BSZ ACCUTRON, INC. 31970 00813830021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other