BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2023050-2017-05006

    MDR report key: 6347174 · Received February 21, 2017

    Report

    Report Number
    2023050-2017-05006
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    January 26, 2017
    Report Date
    December 1, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): UNIT RECEIVED FOR COMPLAINT OF HIGH FIO2 READING COULD NOT BE DUPLICATED. FOUND DIFFERENT ISSUE IN THAT THE MIXER READS LOW THROUGH OUT TESTING. MIXER (SERIAL NUMBER: (B)(4)) WAS ATTACHED TO A TEST HT70 AND A CALIBRATED PTS2000 AND ALLOWED TO CYCLE UNDER STANDARD TEST SETTINGS. WHEN SET AT 21, 40, 60 AND 80 ON THE MIXER THE HT70 READS 22 AND THE PTS200 READS 20.6. WITH THE MIXER SET TO 100 THE HT70 READS 24 AND THE PTS2000 READS 23.6. CALIBRATED THREAD GAUGE WAS USED TO VERIFY THREAD WHERE THE HOSE ATTACHES TO THE MIXER, PASSED. THE MIXER WAS DISASSEMBLED FOR INTERNAL INSPECTION. FOUND CLEAN FILTER. FOUND INTERNAL CRACK AT SCREW CONNECTION, IMAGE ATTACHED. THE ROOT CAUSE OF THE LOW READING COULD NOT BE DETERMINED AND THERE WERE NO OTHER ANOMALIES OBSERVED. PRODUCT ANALYSIS #(B)(4):UNIT RECEIVED FOR COMPLAINT OF HIGH FIO2 READING COULD NOT BE DUPLICATED. FOUND DIFFERENT ISSUE IN THAT THE MIXER READS LOW THROUGH OUT TESTING. MIXER (SERIAL NUMBER: (B)(4)) WAS ATTACHED TO A TEST HT70 AND A CALIBRATED PTS2000 AND ALLOWED TO CYCLE UNDER STANDARD TEST SETTINGS. WHEN THE MIXER IS SET AT 21 THE HT70 READS 24 AND THE PTS READS 23.4, WHEN SET AT 40 THE HT70 READS 37 AND THE PTS READS 35.7, WHEN SET AT 60 THE HT70 READS 39 AND THE PTS READS 38.4, WHEN SET AT 80 THE HT70 READS 41 AND THE PTS READS 41.1, WHEN SET AT 100 THE HT 70 READS 54 AND THE PTS READS 54.2. CALIBRATED THREAD GAUGE WAS USED TO VERIFY THREAD WHERE THE HOSE ATTACHES TO THE MIXER, PASSED. THE MIXER WAS DISASSEMBLED FOR INTERNAL INSPECTION. FOUND CLEAN FILTER. FOUND INTERNAL CRACK AT SCREW CONNECTIONS. THE ROOT CAUSE OF THE LOW READING COULD NOT BE DETERMINED AND THERE WERE NO OTHER ANOMALIES OBSERVED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A MIXER WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. THE MIXER WAS DISASSEMBLED AND A VISUAL INSPECTION WAS PERFORMED, A CRACK WAS FOUND AT THE SCREW CONNECTION. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONALITY TESTING WAS PERFORMED. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE ROOT CAUSE WAS ISOLATED TO CRACK ON THE SCREW CONNECTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS EVALUATED AND THE OXYGEN MIXER WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR'S OXYGEN READINGS READ HIGHER THAN SET VALUES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. VENTILATION WAS NOT INTERRUPTED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. THE VENTILATOR WAS EVALUATED AND THE OXYGEN MIXER WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR'S OXYGEN READINGS READ HIGHER THAN SET VALUES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. VENTILATION WAS NOT INTERRUPTED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128740 CBK NEWPORT MEDICAL INSTRUMENTS, INC MXL70A-GR-DS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention