BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2960538 · Received January 24, 2013

    Report

    Report Number
    2023050-2013-00050
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 8, 2013
    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

    Description of Event or Problem · 1

    REPORTEDLY, WHILE REPLACING THE O2 SENSOR, AN "O2 SENSOR ERROR" ALARM OCCURRED. UPON REPLACING THE O2 SENSOR, THE ISSUE WAS RESOLVED. SOON AFTER THE SAME ERROR OCCURRED AND REPLACING THE O2 SENSOR CABLE RESOLVED THE ISSUE. THERE WAS NO PT INVOLVEMENT REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33906 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E360

    Patients

    Seq Age Sex Outcome Treatment
    1