BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2027446 · Received February 8, 2011

    Report

    Report Number
    2023050-2011-00009
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS PENDING COMPLETION.

    Description of Event or Problem · 1

    REPORTEDLY, WHILE SUCTIONING THE PT, THERE WAS AN AUDIBLE HIGH PRESSURE ALARM AND THEN THE VENTILATOR REPORTEDLY STOPPED DELIVERING BREATHS. THE THERAPIST WAS IN THE ROOM AT THE TIME AND REMOVED THE PT FROM THE VENTILATOR AND BEGAN BAGGING THE PT. NO PERMANENT PT INJURY OCCURRED 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