BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2781844 · Received October 5, 2012

    Report

    Report Number
    2023050-2012-00196
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 17, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING SET UP, THERE WAS A 'HIGH FIO2' ALARM. CALIBRATION OF THE OXYGEN SENSOR RESULTED IN AN "O2 SENSOR ERROR". THE ISSUE WAS RESOLVED BY REPLACING THE SENSOR. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1