BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLOWMETER

    MDR report key: 13297067 · Received January 19, 2022

    Report

    Report Number
    2020813-2022-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 19, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS REACHED OUT TO THE USER FACILITY FOR FURTHER INFORMATION REGARDING THE IMPACTED PATIENTS AND PROCEDURES; HOWEVER, THE FACILITY DECLINED TO PROVIDE ADDITIONAL DETAILS SURROUNDING THESE EVENTS AT THIS TIME. THE DIGITAL ULTRA 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 FLOWMETER UNIT SUBJECT OF THE EVENT IS BEING RETURNED TO ACCUTRON FOR EVALUATION. FINDINGS OF THE EVALUATION WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS REACHED OUT TO THE USER FACILITY FOR FURTHER INFORMATION REGARDING THE IMPACTED PATIENTS AND PROCEDURES; HOWEVER, THE FACILITY DECLINED TO PROVIDE ADDITIONAL DETAILS SURROUNDING THESE EVENTS AT THIS TIME. THE DIGITAL ULTRA 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 FLOWMETER UNIT SUBJECT OF THE EVENT IS BEING RETURNED TO ACCUTRON FOR EVALUATION. FINDINGS OF THE EVALUATION WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY CLARIFIED THE REPORTED DESATURATION EVENT. THE PATIENTS' OXYGEN SATURATION WAS BEING MONITORED DURING PROCEDURES AS A STANDARD PRACTICE AND WAS NOTED TO DROP, CAUSING AN ALARM TO GO OFF. NO ADVERSE SYMPTOMS WERE REPORTED. THE UNIT SUBJECT OF THE EVENT WAS RETURNED WITH NOTABLE DAMAGE TO FACTORY-ISSUED PARTS. THE UNIT WAS TESTED AND THE OXYGEN FLOW WAS INTERMITTENT, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. THE UNIT WAS MANUFACTURED IN 2008 AND WAS DETERMINED TO CONTAIN COMPONENTS WHICH WERE NO LONGER SERVICEABLE DUE TO AGE. THEREFORE, THE UNIT HAS BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PATIENTS BECAME DESATURATED DURING PROCEDURES INVOLVING THE ACCUTRON DIGITAL ULTRA FLOWMETER. THE REPORTED EVENT WAS CONFIRMED TO OCCUR ON TWO SEPARATE DATES, IMPACTING TWO PATIENT PROCEDURES.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PATIENTS BECAME DESATURATED DURING PROCEDURES INVOLVING THE ACCUTRON DIGITAL ULTRA FLOWMETER. THE REPORTED EVENT WAS CONFIRMED TO OCCUR ON TWO SEPARATE DATES, IMPACTING TWO PATIENT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942610 DIGITAL ULTRA FLOWMETER FLOWMETER BSZ ACCUTRON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown