BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2852489 · Received November 15, 2012

    Report

    Report Number
    2023050-2012-00270
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 31, 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

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, A "LOW FIO2" ALARM OCCURRED WHICH COULD NOT BE RESOLVED BY CALIBRATING THE OXYGEN SENSOR. REPLACING THE OXYGEN SENSOR RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1