BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, DIGITAL FLUSHMOUNT

    MDR report key: 10997532 · Received December 13, 2020

    Report

    Report Number
    2020813-2020-00002
    Event Type
    Injury
    Date Received
    December 13, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ACCUTRON INC.
    Product Code
    BSZ
    UDI-DI
    00813830020885
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE DIGITAL FLUSHMOUNT FLOWMETER, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENT TO FEEL NAUSEOUS. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE ANY SERIOUS INJURY OR DETERIORATION OF HEALTH. THIS EVENT COULD POTENTIALLY LEAD TO SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THEREFORE CONFIRMATION AND ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. MEDIVATORS 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, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENT TO FEEL NAUSEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462489 FLOWMETER, DIGITAL FLUSHMOUNT FLOWMETER BSZ ACCUTRON INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 Other