BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLUSHMOUNT PACKAGE H

    MDR report key: 18418568 · Received December 29, 2023

    Report

    Report Number
    2020813-2023-00007
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Report Date
    December 29, 2023
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830023510
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY REGARDING THE REPORT OF "PATIENTS REACTING UNUSUAL TO NITROUS" HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE DIGITAL ULTRA FLOWMETER SUBJECT OF THE REPORTED EVENT WAS SENT BACK TO ACCUTRON FOR EVALUATION. EVALUATION RESULTS DETERMINED THAT NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE DEVICE AND THE DIGITAL ULTRA FLOWMETER WAS FOUND TO BE OPERATING ACCORDING TO SPECIFICATION. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PATIENTS ARE "REACTING UNUSUAL TO NITROUS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388961 DIGITAL ULTRA FLUSHMOUNT PACKAGE H FLOWMETER BSZ ACCUTRON, INC. 56800 (10)27013 00813830023510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown