BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC

    MDR report key: 6461946 · Received April 5, 2017

    Report

    Report Number
    2023050-2017-05135
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Report Date
    June 13, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #225066432: UNABLE TO DUPLICATED FAILURE. THE OXYGEN SENSOR WAS INSTALLED INTO THE TEST UNIT TO THE VERIFY SYMPTOM AND PASSED TESTING. THE SETTINGS WERE ADJUSTED TO 30%, 50%, 80% AND 100%. THE TOLERANCE FOR THE OXYGEN SENSOR SHOULD NOT EXCEED +/- 3%. THE FOLLOWING MEASUREMENTS WERE OBTAINED FROM THE SERVOMEX 30.1%, 50.3%, 80.3%, AND 99.5%.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S OXYGEN READINGS WERE HIGHER THAN SET VALUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER DECLINED TO PROVIDE THE TYPE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S OXYGEN READINGS WERE HIGHER THAN SET VALUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER DECLINED TO PROVIDE THE TYPE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242290 NEWPORT MEDICAL INSTRUMENTS, INC VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1