BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, DIGITAL FLUSHMOUNT

    MDR report key: 10649509 · Received October 8, 2020

    Report

    Report Number
    2020813-2020-00001
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ACCUTRON INC.
    Product Code
    BSZ
    UDI-DI
    00813830020885
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE DIGITAL FLUSHMOUNT FLOWMETER WITH 3 PEDIATRIC PATIENTS, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENTS TO FEEL ILL, VOMIT, AND IN RARE EVENTS, PASSING OUT. IT WAS REPORTED THAT THE DENTIST PROVIDED A FLUSH OF OXYGEN TO EACH PATIENT AND SUCCESSFULLY REVERSED THE SYMPTOMS AND NO FURTHER MEDICAL ATTENTION WAS REQUIRED. ACCUTRON RECEIVED THE FLOWMETER FROM THE USER FACILITY FOR PRODUCT ANALYSIS AND TESTING INDICATED THAT THIS SITUATION OCCURRED DUE TO FLUCTUATION IN THE POWER SUPPLY OUTPUT OF THE DEVICE. THE NEGATIVE SPIKES IN THE POWER SUPPLY OUTPUT OCCURRED INTERMITTENTLY DURING TESTING. ACCUTRON WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE DIGITAL FLUSHMOUNT FLOWMETER WITH 3 PEDIATRIC PATIENTS, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENTS TO FEEL ILL, VOMIT, AND IN RARE EVENTS, PASSING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117692 FLOWMETER, DIGITAL FLUSHMOUNT FLOWMETER BSZ ACCUTRON INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 Other