BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2960534 · Received January 24, 2013

    Report

    Report Number
    2023050-2013-00056
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, A "HIGH FIO2" ALARM OCCURRED THAT COULD NOT BE SOLVED BY CALIBRATING THE OXYGEN SENSOR. UPON REPLACING THE SENSOR, THIS ISSUE WAS RESOLVED. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33904 E360 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS E360

    Patients

    Seq Age Sex Outcome Treatment
    1