BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, DIGITAL FLEXMOUNT, WALL ARM

    MDR report key: 22749097 · Received August 8, 2025

    Report

    Report Number
    2020813-2025-00007
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830025149
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE AND THOROUGH TEST AND EVALUATION WAS CONDUCTED OF THIS UNIT IN AS RECEIVED CONDITION AND COULD NOT DUPLICATE REPORTED PROBLEM UNIT MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    WHENEVER ANY PATIENTS WERE COMING OFF OF THE NITROUS, THEY WERE GETTING NAUSEOUS AND VOMITING (THIS OCCURRED IN SEVERAL INSTANCES); 1 OF THEM ALSO GOT EXTREMELY EMOTIONAL AFTER THE NITROUS, AND HE WASN'T LIKE THIS BEFOREHAND (SO THAT WAS VERY QUESTIONABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065146 FLOWMETER, DIGITAL FLEXMOUNT, WALL ARM FLOWMETER BSZ ACCUTRON, INC. 26400-WA 00813830025149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other