BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL ULTRA FLUSHMOUNT PACKAGE H

    MDR report key: 23620054 · Received November 21, 2025

    Report

    Report Number
    2020813-2025-00010
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830023510
    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 OF DEVICE IN AS RECEIVED CONDITION AND COULD NOT DUPLICATE REPORTED PROBLEM. DEVICE MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED PATIENTS GETTING SICK ON N2O. TWO PATIENTS VOMITED MID-TREATMENT ON DIFFERENT DAYS IN THIS SAME ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560567 DIGITAL ULTRA FLUSHMOUNT PACKAGE H FLOWMETER AND SCAVANGING CIRCUIT BSZ ACCUTRON, INC. 56800 00813830023510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other