BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, DIGITAL FLUSHMOUNT

    MDR report key: 24639176 · Received March 19, 2026

    Report

    Report Number
    2020813-2026-00001
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 27, 2026
    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

    DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED TO MANUFACTURER. TEST AND EVALUATION WAS CONDUCTED IN AS RECEIVED CONDITION AND COULD NOT DUPLICATE REPORTED PROBLEM OF HIGH N2O FLOW. WHEN O2 GAS WAS NOT PRESENT, N2O WOULD NOT FLOW, PROVING FAILSAFE SYSTEM IS WORKING. DEVICE MEETS FACTORY SPECIFICATION. LIKEWISE, THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE UNIT THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE.

    Description of Event or Problem · 0

    DISTRIBUTOR STATED THAT (B)(6) REPORTED THAT DURING PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS AND NAUSEA. ACCORDING TO THE OPERATOR, EVEN WHEN THE NITROUS OXIDE CONCENTRATION WAS SET TO 0% (OXYGEN-ONLY MODE), THE PATIENT STILL APPEARED TO BE AFFECTED AS IF NITROUS OXIDE WAS BEING DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176550 FLOWMETER, DIGITAL FLUSHMOUNT FLOWMETER BSZ ACCUTRON, INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other