BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

    MDR report key: 6149947 · Received December 6, 2016

    Report

    Report Number
    2021710-2016-04985
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 6, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZR
    PMA / PMN Number
    K883038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROBLENDER WAS BEING USED ON THE INCUBATOR DURING TRANSPORT AND THERE WAS NO BYPASS AUDIBLE ALARM PRESENT WHEN THE OXYGEN GAS WAS CONNECTED WITHOUT THE AIR GAS SOURCE CONNECTED. IT IS UNKNOWN IF THERE WAS ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798503 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 Other