BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PC% FLOWMETER

    MDR report key: 18049724 · Received November 1, 2023

    Report

    Report Number
    2020813-2023-00004
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Report Date
    November 1, 2023
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830021158
    PMA / PMN Number
    K970163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUTRON REQUESTED AND RECEIVED THE UNIT SUBJECT OF THE EVENT FOR EVALUATION. THE UNIT WAS TESTED AND WAS FOUND TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE ULTRA PC% FLOWMETER USER MANUAL STATES (2), "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. IF PATIENT DOES NOT SHOW SIGNS OF QUICK RECOVERY, REMOVE NASAL MASK AND TREAT WITH PURE OXYGEN FROM EITHER THE O2 RESUSCITATOR FITTING OR AN AUXILIARY OXYGEN TANK USING A DEMAND VALVE, OXYGEN ASSISTED MANUAL RESUSCITATOR, OR EQUIVALENT. CALL FOR EMERGENCY ASSISTANCE IF RAPID RESPONSE IS NOT ACHIEVED." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES INVOLVING THE ULTRA PC % FLOWMETER, THREE PATIENTS WOKE UP AND BEGAN TO VOMIT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025692 ULTRA PC% FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 31975 (10)2637971 00813830021158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown