BEUDAMED
    FDA Adverse Event Other Summary report: N

    E500 VENTILATOR

    MDR report key: 1842564 · Received September 14, 2010

    Report

    Report Number
    2023050-2010-00036
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 17, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    REPORTEDLY, 30 MINUTES AFTER THE INITIATION OF VENTILATION, THE PT'S SPO2 SUDDENLY DECREASED AND THE PT BREATHED SPONTANEOUSLY. THE APPROPRIATE VENTILATOR ALARMS WERE PRODUCED. MANUAL VENTILATION WAS EMPLOYED TO INCREASE THE PT'S SPO2. THE PT WAS THEN TRANSFERRED TO A SECOND VENTILATOR. NOTE: NO PERMANENT PT INJURY OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention