BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2770072 · Received September 28, 2012

    Report

    Report Number
    2023050-2012-00191
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    NEWPORT MEDICLA INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING TESTING, THE VENTILATOR ALWAYS ALARMED WITH 'FIO2 HIGH ERROR MESSAGE. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS SOLVED BY REPLACING THE O2 SENSOR. NO PT INVOLVED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICLA INSTRUMENT E360

    Patients

    Seq Age Sex Outcome Treatment
    1