BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DC FLOWMETER

    MDR report key: 24781789 · Received April 3, 2026

    Report

    Report Number
    2020813-2026-00002
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 3, 2026
    Manufacturer
    ACCUTRON INC
    Product Code
    BSZ
    UDI-DI
    00813830021219
    PMA / PMN Number
    K970163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    PEDIATRIC PATIENT WAS UNABLE TO WAKE UP AFTER PROCEDURE. EMERGENCY SERVICES WERE CALLED BUT PATIENT WOKE UP BEFORE THEIR ARRIVAL. PATIENT IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838102 ULTRA DC FLOWMETER ANESTHESIA GAS MACHINE BSZ ACCUTRON INC 31980 00813830021219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other