BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2770031 · Received September 28, 2012

    Report

    Report Number
    2023050-2012-00192
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    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

    DURING INITIAL INSTALLATION OF A BRAND NEW VENTILATOR AT THE USER FACILITY, FIO2 MEASURED 60% WHEN SET AT 100%. WHEN CALIBRATING THE O2 SENSOR, 'O2 SENSOR ERROR' ALARM OCCURRED. REPLACING THE O2 SENSOR RESOLVED THE ISSUE. THE ORIGINAL O2 SENSOR WAS INSTALLED IN THE KNOWN GOOD UNIT CONFIRMING THE PROBLEM. NO PT INVOLVED IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1