BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2141067 · Received June 15, 2011

    Report

    Report Number
    2023050-2011-00023
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR GAVE VISUAL LED ALARM AND AUDIBLE ALARM. HOWEVER, THE ALARM SETUP SCREEN DOES NOT SHOW ANY PROBLEMS WITH THE PRESSURE SETUP OR ANY OF THE SETTINGS ON THE VENTILATOR. THE PRESSURE BAR GRAPH ON THE VENTILATOR INITIALLY SEEMED TO HAVE MOMENTARILY PAUSED AND DISPLAYED A CONSTANT BASELINE PRESSURE. THE PRESSURE BAR GRAPH THEN RESUMED RISING WITHOUT ANY PROBLEMS. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO THE BACKUP VENTILATOR DUE TO THIS ISSUE. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention