BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR

    MDR report key: 18290959 · Received December 8, 2023

    Report

    Report Number
    2020813-2023-00006
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 8, 2023
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830024258
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER SUBJECT OF REPORTED EVENT WAS RETURNED FOR EVALUATION. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE FLOWMETER WERE IDENTIFIED. THE UNIT WAS CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION; THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. USER FACILITY PERSONNEL WERE COUNSELED ON THE PROPER USE AND OPERATION FOR THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER. THE INSTRUCTIONS FOR USE STATES, WARNINGS: 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." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE PATIENT SUBJECT OF THE EVENT SOUGHT MEDICAL EVALUATION FOLLOWING THE REPORTED EVENT. THE UNIT WAS REMOVED FROM SERVICE. ACCUTRON HAS REQUESTED THAT THE UNIT SUBJECT OF THE REPORTED EVENT TO BE RETURNED FOR EVALUATION. OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER, THE PATIENTS O2 SATURATION BEGAN TO DROP. THE PROCEDURE WAS STOPPED AND MEDICAL INTERVENTION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259018 DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR FLOWMETER BSZ ACCUTRON, INC. 56800-CHAIR (10)2787222 00813830024258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown