BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 4623617 · Received March 17, 2015

    Report

    Report Number
    2021710-2015-00554
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    K883038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALLEGED FAULTY DEVICE WAS RECEIVED BY CAREFUSION ON MARCH 10, 2015, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: MICROBLENDER PN: 10049A, SN: (B)(4) WAS RECEIVED INTO THE CAREFUSION FAILURE ANALYSIS LAB FOR INVESTIGATION. THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN EXAMINED THE MICROBLENDER AND FOUND THAT IT IS OUT OF CALIBRATION. THE MICROBLENDER WAS TESTED ON TEST STATION # 10464 PER DRS 91640 AND FOUND THAT IT IS OUT OF CALIBRATION AT 21%, 60% O2. AT END POINT CALIBRATION SEQUENCE # 1, 21%, SPEC. IS 20.9 TO 22.9% READS 22.1%. AT SET POINT CALIBRATION SEQUENCE # 3, 60%, SPEC. IS 58.0 TO 62.0% READS 58.3%. AT SET POINT CALIBRATION SEQUENCE # 4, 90%, SPEC. IS 88.0 TO 92.0% READS 89.5%. AT SET POINT CALIBRATION SEQUENCE # 5, 100%, SPEC. IS 98.0 TO 100.0% READS 98.5%. AT SET POINT CALIBRATION SEQUENCE # 8, 60%, SPEC. IS 57.0 TO 63.0% READS 54.8%. ADDITIONAL ISSUE RELATED TO COMPLAINT; AT SET POINT CALIBRATION SEQUENCE # 2, 30%, SPEC. IS 28.0 TO 32.0% READS 27.5%. THE MICROBLENDER WAS RECALIBRATED BY ADJUSTING THE CONTROL KNOB. FINDING/ROOT-CAUSE: THE MICROBLENDER WAS OUT OF CALIBRATION AT 60% BUT WAS NOT OUT OF CALIBRATION AT 21%, 90% AND 100%, AS ALLEGED, BUT WAS OUT OF CALIBRATION AT 30%.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO AN EMAIL FROM THE DISTRIBUTOR IN AUSTRALIA. "OXYGEN CONCENTRATION READINGS FAILED PRE-DELIVERY INSPECTION OUT OF SPEC. OUT OF BOX FAILURE 21:24.4, 30:30.7, 60:57.8, 90:86.4, 100:97.1".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182744 BIRD MIXER, BREATHING GASES, ANESTHEISAINHALATION BZR CAREFUSION MICROBLENDER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA