BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR, JAPANESE EXPANDED

    MDR report key: 2894441 · Received December 27, 2012

    Report

    Report Number
    2023050-2012-00361
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    September 19, 2012
    Report Date
    December 6, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    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, NO ADDITIONAL PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, LOW FIO2 AND HIGH FIO2 ALARM OCCURRED. CALIBRATING THE O2 SENSOR DID NOT SOLVE THE ISSUE. REPLACING THE O2 SENSOR RESOLVED THE ISSUE. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1