BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 2831734 · Received November 9, 2012

    Report

    Report Number
    2023050-2012-00263
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 18, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, THE DISPLAY BECAME NON FUNCTIONAL. THE VENTILATOR KEPT VENTILATING AT THIS TIME. THE VENTILATOR WAS THEN ATTEMPTED TO BE RESTARTED; HOWEVER, THE DISPLAY REMAINED WHITE SCREEN AND THE VENTILATOR DID NOT RESUME. SINCE THE SETTING WAS UNABLE TO BE CHANGED, THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention