BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PC% CABINET MOUNT FLOWMETER

    MDR report key: 15735581 · Received November 4, 2022

    Report

    Report Number
    2020813-2022-00006
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    July 14, 2022
    Report Date
    November 4, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830023701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS CONTACTED THE USER FACILITY REQUESTING THE DEVICE SUBJECT OF THE EVENT BE RETURNED TO ACCUTRON FOR EVALUATION. THE INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY INDICATED THE REPORTED EVENT OCCURRED ON JULY 14, 2022 AND ACCUTRON WAS FIRST MADE AWARE OF THIS ISSUE ON OCTOBER 7, 2022. THE USER FACILITY HAS CONTINUED TO USE THE UNIT SUBJECT OF THE EVENT SINCE JULY 2022 AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THROUGH FOLLOW-UP WITH THE USER FACILITY, ACCUTRON LEARNED THAT IMMEDIATELY FOLLOWING THE REPORTED EVENT USER FACILITY PERSONNEL HAD ADMINISTERED 100% OXYGEN FOR 10 MINUTES AND THE PATIENT RECOVERED. AS A PRECAUTION, THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION. ACCUTRON REQUESTED AND RECEIVED THE UNIT SUBJECT OF THE EVENT FOR EVALUATION. THE UNIT WAS TESTED AND FOUND TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE ULTRA PC% CABINET MOUNT FLOWMETER INSTRUCTIONS FOR USE STATES, "TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE. PATIENT SHOULD ALWAYS BE CLOSELY MONITORED DURING NITROUS OXIDE USE. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED. THE O2 FLUSH BUTTON CAN BE USED TO RAPIDLY PURGE THE LINES OF N2O.". ACCUTRON COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE FLOWMETER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE ULTRA PC% FLOWMETER THE PATIENT WENT BLUE AND STARTED SEIZING. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND WAS REPORTED TO HAVE FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214031 ULTRA PC% CABINET MOUNT FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 27514 00813830023701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown