BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1661574 · Received April 12, 2010

    Report

    Report Number
    2023050-2010-00012
    Event Type
    Other
    Date Received
    April 12, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 16, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE ON A PATIENT, THE NURSE HEARD THAT THE VENTILATOR WAS GIVING FIO2 ALARM. WHEN THE NURSE CHECKED THE VENTILATOR, THERE WAS NO GAS FLOW FROM THE BREATHING CIRCUIT. THE PATIENT WAS AMBU BAGGED TO PRECLUDE PERMANENT INJURIES.

    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 UNK Required Intervention