BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2934938 · Received January 4, 2013

    Report

    Report Number
    2023050-2013-00015
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 18, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    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 PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PATIENT USE, A 'HIGH O2' ALARM OCCURRED. CALIBRATING THE O2 SENSOR DID NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. THERE WAS NO SERIOUS INJURY REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5806 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E360

    Patients

    Seq Age Sex Outcome Treatment
    1