Events

Recall of Newport e360 Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Newport Medical Instruments Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58620
  • Event Risk Class
    Class 2
  • Event Number
    Z-2468-2011
  • Event Initiated Date
    2009-10-27
  • Event Date Posted
    2011-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99720
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
  • Action
    Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.

Device

Newport e360 Ventilator
  • Model / Serial
    Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
  • Product Description
    Newport e360 Ventilator, Model Number: e360 || The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Manufacturer Address
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA