BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, DIGITAL FLUSHMOUNT

    MDR report key: 23485443 · Received November 6, 2025

    Report

    Report Number
    2020813-2025-00009
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830020885
    PMA / PMN Number
    K052335
    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. BOTH THE DIGITAL MAIN MODULE AND THE CONTROL MODULE MEET FACTORY SPECIFICATIONS. NO REPAIRS OR RECALIBRATION NECESSARY.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED THAT A PATIENT PASSED OUT WITHIN MINUTES OF USING NITROUS. AN AMBULANCE WAS CALLED, AND PATIENT WAS SENT TO THE HOSPITAL. ACCORDING TO HOSPITAL REPORT PATIENT WAS FINE; HAD AN ANXIETY ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2682229 FLOWMETER, DIGITAL FLUSHMOUNT FLOWMETER BSZ ACCUTRON, INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other