BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

    MDR report key: 6108217 · Received November 16, 2016

    Report

    Report Number
    2021710-2016-04844
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 16, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZR
    PMA / PMN Number
    K883038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT NO PARTS ARE AVAILABLE FOR RETURN THEREFORE NO EVALUATION CAN BE COMPLETE ON THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ALARM ON THIS BLENDER DOESN'T SOUND WHEN ONE GAS IS LOST ALTHOUGH THERE IS GAS COMING INTO THE ALARM CAP. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757900 P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR CAREFUSION, INC LOW FLOW MICROBLENDER

    Patients

    Seq Age Sex Outcome Treatment
    1