BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER

    MDR report key: 6115191 · Received November 18, 2016

    Report

    Report Number
    2021710-2016-04862
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 18, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZR
    PMA / PMN Number
    K973646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: THE BLENDER WAS RETURNED TO THE FACTORY SERVICE DEPARTMENT WHERE THE FAILURE WAS CONFIRMED AND ISOLATED TO THE BLENDER BEING OUT OF CALIBRATION. THE BLENDER WAS RE-CALIBRATED AND RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FIO2 ON THIS BLENDER IS OUT OF SPECIFICATION. WHEN SET TO 21% OXYGEN, THE EXTERNAL ANALYZER READS 27% AND WHEN SET AT 60% THE ANALYZER READS 67%. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764221 BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR CAREFUSION, INC HIGH FLOW OMNIBLENDER

    Patients

    Seq Age Sex Outcome Treatment
    1