“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.
Worldwide distribution: USA including states of CA, KY, NM, NY, UT and internationally to: Armenia, Bolivia, Brazil, Bulgaria, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Malaysia, Mauritius, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, South Africa, Sri Lanka, Syria, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, Vietnam.
Description du dispositif
Newport e360 Ventilator || 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.
Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, England, Finland, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Japan, Jordan, Kazahkstan, Kenya, Korea, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nambia, Nepal, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, AUE, Ukraine, United Kingdom, Yemen Republic and Zimbabwe.
Description du dispositif
Newport e360 Ventilator, Rx only. || 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).
Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
Description du dispositif
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.