BEUDAMED
    FDA Adverse Event Death Summary report: N

    P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

    MDR report key: 14812456 · Received June 25, 2022

    Report

    Report Number
    2021710-2022-16346
    Event Type
    Death
    Date Received
    June 25, 2022
    Date of Event
    June 20, 2022
    Report Date
    June 20, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZR
    UDI-DI
    10846446002348
    PMA / PMN Number
    K883038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICROBLENDER WAS INCORRECTLY SET TO 21% FIO2 (FRACTION OF INSPIRED OXYGEN). THE PATIENT WAS IN CRITICAL DESATURATION WHILE USING THE OPTIFLOW THRIVE. THE PATIENT HAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634843 P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR VYAIRE MEDICAL MICROBLENDER 10846446002348

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death