BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC.

    MDR report key: 6497568 · Received April 17, 2017

    Report

    Report Number
    2023050-2017-05172
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OXYGEN READINGS WERE OUT OF RANGE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE OXYGEN MIXER WAS REPLACED. THE VENTILATOR PASSED SELF-TESTING. THE CUSTOMER DID NOT PROVIDE DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278708 NEWPORT MEDICAL INSTRUMENTS, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1