BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLUSHMOUNT FLOWMETER

    MDR report key: 13426088 · Received February 2, 2022

    Report

    Report Number
    2020813-2022-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 4, 2022
    Report Date
    February 2, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830020885
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SUBJECT OF THE EVENT SOUGHT MEDICAL EVALUATION FOLLOWING THE REPORTED EVENT. FOLLOWING THE EVENT, THE TECHNICIAN NOTED THAT GAS APPEARED TO CONTINUE TO FLOW AND THE BAG APPEARED TO INFLATE AFTER THE FLOWMETER HAD BEEN POWERED OFF. A NEW FLOWMETER UNIT WILL BE INSTALLED AT THE USER FACILITY. THE DIGITAL FLUSHMOUNT FLOWMETER INSTRUCTIONS FOR USE STATES, "TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE, USING TITRATION METHOD. 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." THE UNIT SUBJECT OF THE EVENT IS BEING RETURNED TO ACCUTRON. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INFORMATION REGARDING THE UNIT CONDITION AND EVALUATION UPON RECEIPT OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED TO ACCUTRON FOR EVALUATION. THE EVALUATION FOUND THAT AN AMPLIFIER ON THE MAIN CIRCUIT BOARD WAS NOT OPERATING PROPERLY RESULTING IN THE REPORTED EVENT. THE CAUSE OF THE FAILURE OF THE COMPONENT COULD NOT BE DETERMINED. POSSIBLE CAUSES OF THE FAILURE INCLUDE VOLTAGE SPIKES IN FACILITY POWER OR MECHANICAL SHOCK (PHYSICAL DAMAGE) FROM BEING DROPPED OR IMPACTED. THE DIGITAL FLUSHMOUNT FLOWMETER INSTRUCTIONS FOR USE STATES, "TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE, USING TITRATION METHOD. 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 HOOD 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.". A REVIEW OF COMPLAINTS INDICATES THIS TO BE AN ISOLATED EVENT. A NEW UNIT WAS INSTALLED AT THE USER FACILITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE ACCUTRON DIGITAL FLUSHMOUNT FLOWMETER, THE PATIENT BEGAN TO VOMIT AND BECAME UNRESPONSIVE. THE PROCEDURE WAS STOPPED AND MEDICAL INTERVENTIONS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16202 DIGITAL ULTRA FLUSHMOUNT FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown