BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 3851110 · Received May 22, 2014

    Report

    Report Number
    2023050-2014-00215
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN INVESTIGATION VERIFIED THE CUSTOMER COMPLAINT OF THE O2 SENSOR ERROR. INSPECTION OF THE O2 FILTER FOUND IT HAD A BROKEN END AND TUBING HAD BECOME DISCONNECTED. TUBING WAS RECONNECTED AND CALIBRATIONS WERE PERFORMED. THE UNIT THEN PASSED TESTING AND WAS RUN OVERNIGHT WITHOUT ANY FURTHER EVENTS. THE CUSTOMER REPORTED TO HAVE REPLACED THE BATTERY. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THAT DURING PATIENT USE, A LOW FI02 (FRACTIONAL INSPIRED OXYGEN) ALARM, A HIGH FI02 ALARM, AND A FLOW SENSOR ERROR ALARM OCCURRED ON AN E360 VENTILATOR. THE PATIENT WAS MANUALLY VENTILATED AND THEN TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306730 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention