BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1677075 · Received May 3, 2010

    Report

    Report Number
    2023050-2010-00013
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR WENT INTO DEVICE ALERT AND SHUT DOWN ON A PATIENT. THE PATIENT WAS AMBU BAGGED AND THEN SWITCHED TO THE BACKUP VENTILATOR. PLEASE NOTE THAT NO PERMANENT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    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