BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2770028 · Received September 28, 2012

    Report

    Report Number
    2023050-2012-00188
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 17, 2012
    Report Date
    September 3, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, PT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, A 'LOW FIO2' ALARM OCCURRED. REPLACING THE O2 SENSOR RESOLVED THE ISSUE. NO SERIOUS INJURY WAS REPORTED 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