BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1613084 · Received February 19, 2010

    Report

    Report Number
    2023050-2010-00008
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 26, 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
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE VENTILATOR WAS FIRST TURNED ON, IT BEGAN VENTILATION WITHOUT ENTERING STANDBY CONDITION TO PERFORM THE CIRCUIT CHECK. THE PT WAS CONNECTED TO THE VENTILATOR WITHOUT A VERIFICATION OF FUNCTIONALITY BY THE USER. SOON AFTER, THE PT WAS REMOVED FROM THE VENTILATOR BECAUSE THE VENTILATOR GAVE A DEVICE ALERT WITH AN ERROR MESSAGE "CIRCUIT DISCONNECT". ALSO, PEEP PRESSURE WAS NOT BEING DELIVERED AS SET. THE PT WAS MANUALLY VENTILATED AND THEN SWITCHED TO ANOTHER VENTILATOR. REPLACING THE ANALOG BOARD FIXED THE REPORTED PROBLEM.

    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