BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT FLOWMETER SYSTEM

    MDR report key: 15933120 · Received December 7, 2022

    Report

    Report Number
    2020813-2022-00008
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830023305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY WAS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE NEWPORT FLOWMETER SYSTEM; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY INDICATED THE ISSUE WAS INTERMITTENT AND THEY DO NOT HAVE AN EXACT NUMBER OF PATIENTS IMPACTED. ACCUTRON WAS FIRST MADE OF AWARE OF THIS ISSUE ON NOVEMBER 10, 2022. THE UNIT SUBJECT OF THE EVENT WAS RETURNED TO ACCUTRON FOR EVALUATION. THE GAS FLOWS WERE TESTED AND CONFIRMED TO BE OPERATING PROPERLY. DURING THE EVALUATION IT WAS FOUND THAT THE ON/OFF VALVE REQUIRED REPLACEMENT. THIS CAUSED AN OXYGEN LEAK WHEN THE VALVE WAS IN THE OFF POSITION. THE ISSUE WITH THE VALVE WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE NEWPORT FLOWMETER SYSTEM USER MANUAL STATES (2), "WARNINGS 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. 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." ACCUTRON MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. ACCUTRON WILL OFFER IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE NEWPORT FLOWMETER SYSTEM.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES INVOLVING THE NEWPORT FLOWMETER PATIENTS BECAME NAUSEOUS AND SOME BEGAN TO VOMIT. THE PATIENTS WERE ADMINISTERED OXYGEN AND FULLY RECOVERED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043836 NEWPORT FLOWMETER SYSTEM FLOWMETER BSZ ACCUTRON, INC. 50000 00813830023305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown