BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2187567 · Received July 19, 2011

    Report

    Report Number
    2023050-2011-00030
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 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 SCREEN WAS BLANK AND IT DID NOT DISPLAY ANY ERROR MESSAGES. ALSO, THE PRESSURE BAR GRAPH ON THE VENTILATOR SEEMED TO HAVE MOMENTARILY PAUSED. ONCE THE ALARM SETTING SCREEN WAS OPENED BY THE USER, THE PRESSURE BAR GRAPH THEN RESUMED RISING WITHOUT ANY PROBLEMS. THIS ISSUE HOWEVER, RECURRED AFTER ONE HR. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO THE BACKUP VENTILATOR DUE TO THIS ISSUE. PLEASE NOTE THAT NO PERMANENT INJURY WAS REPORTED 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 69 YR Required Intervention