BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC.

    MDR report key: 6460107 · Received April 5, 2017

    Report

    Report Number
    2023050-2017-05133
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 3, 2017
    Report Date
    June 13, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4):FAILURE DUPLICATED. THE OXYGEN SENSOR WAS PLACED INTO A TEST UNIT AND FAILED TESTING WHEN THE SETTING WAS CHANGED TO 50% WITHIN 10 MINUTES. THE SENSOR WAS CALIBRATED AND TESTED AT THE FOLLOWING RATES: 21%, 40%, 60%, 80% AND 100%. THE FOLLOWING RESULTS WERE OBSERVED 21.3%, 40.3%, 58.7%, 79.8%, 99.8%, ALL TEST TRAILS ARE WITHIN TOLERANCE OF +/- 3% AND HAVE PASSED TESTING. DURING TESTING THE SYSTEM WAS ALLOWED TO RUN FOR APPROXIMATELY 25 MINUTES. THE ROOT CAUSE WAS DUE TO THE SENSOR NEEDING CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE OXYGEN SENSOR. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE DEVICE WAS EVALUATED AND THE OXYGEN SENSOR WAS REPLACED. THE DEVICE PASSED SELF-TESTING. REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME. THE CUSTOMER DECLINED TO PROVIDE THE DEVICE TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE OXYGEN SENSOR. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE DEVICE WAS EVALUATED AND THE OXYGEN SENSOR WAS REPLACED. THE DEVICE PASSED SELF-TESTING. REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244220 NEWPORT MEDICAL INSTRUMENTS, INC. CBK NEWPORT MEDICAL INSTRUMENTS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1