BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 4623636 · Received March 17, 2015

    Report

    Report Number
    2021710-2015-00552
    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). CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR THE RETURN OF THE ALLEGED FAULTY DEVICE FOR EVALUATION. AS OF THE MARCH 17, 2015 THE ALLEGED FAULTY DEVICE HAS NOT BEEN RECEIVED. ONCE THE ALLEGED FAULTY DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE ANALYSIS: MICROBLENDER PN: 03920A, 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 (B)(4) AND FOUND THAT IT IS OUT OF CALIBRATION AT 21% AND 30% O2. AT END POINT CALIBRATION SEQUENCE # 1, 21%, SPEC. IS 20.9 TO 22.9% READS 26.7%. AT SET POINT CALIBRATION SEQUENCE # 2, 30%, SPEC. IS 28.0 TO 32.0% READS 27.8%. AT SET POINT CALIBRATION SEQUENCE # 3, 60%, SPEC. IS 58.0 TO 62.0% READS 58.0%. AT SET POINT CALIBRATION SEQUENCE # 4, 90%, SPEC. IS 88.0 TO 92.0% READS 91.1%. AT SET POINT CALIBRATION SEQUENCE # 5, 100%, SPEC. IS 98.0 TO 100.0% READS 99.6%. AT SET POINT CALIBRATION SEQUENCE # 7, 60%, SPEC. IS 58.0 TO 62.0% READS 58.8%. AT SET POINT CALIBRATION SEQUENCE # 8, 60%, SPEC. IS 57.0 TO 63.0% READS 59.2%. AT SET POINT CALIBRATION SEQUENCE # 9, 60%, SPEC. IS 57.0 TO 63.0% READS 58.7%. THE MICROBLENDER WAS RECALIBRATED BY ADJUSTING THE VALVE SEAT AND THE CONTROL KNOB. HOWEVER, IT WAS FOUND THAT THE BEST CALIBRATION YIELDED READINGS OF AT 21%; 22.7, 30%; 29.2, 60%; 60.3, 90%; 89.1, 100%; 100.0. THE POPPET PN: 03929 WAS REPLACED WITH A KNOWN GOOD POPPET AND NOW THE MICROBLENDER CAN BE CALIBRATED AS FOLLOWS 21%; 21.3, 30%; 29.9, 60%; 59.5, 90%; 89.5, 100%; 99.6. DUPLICATED, THE MICROBLENDER IS OUT OF CALIBRATION AT 21% AND 30% BUT DID NOT DUPLICATE MICROBLENDER OUT OF CALIBRATION AT 60%, 90% AND 100% COMPLAINT ALLEGATION. FINDING/ROOT-CAUSE: THE MICROBLENDER WAS OUT OF CALIBRATION DUE TO A FAULTY POPPET PN: 03929.

    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 21:30.3, 30:32.5, 60:56.1, 90:83.2, 100:97.2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181127 BIRD MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR CAREFUSION MICROBLENDER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA