BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

    MDR report key: 6183743 · Received December 16, 2016

    Report

    Report Number
    2021710-2016-05054
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 16, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZR
    PMA / PMN Number
    K883038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). THE CAREFUSION FACTORY SERVICE RECEIVED THE SUSPECT DEVICE FOR EVALUATION AND REPAIR. THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED AS THE BLENDER FAILED FACTORY CALIBRATION SPECIFICATIONS. AFTER RE-CALIBRATING THE BLENDER AND PERFORMING FURTHER TESTING, THE DEVICE MEETS SERVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE LOW FLOW AIR/OXYGEN MICROBLENDER; THE DELIVERED OXYGEN WAS OUT OF SPECIFICATIONS. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832365 P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR CAREFUSION, INC LOW FLOW AIR/OXYGEN MICROBLENDER

    Patients

    Seq Age Sex Outcome Treatment
    1