FDA-Device2015-06-03Class I
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Carefusion 211 Inc dba Carefusion
Hazard
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Sold states
Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvadore, Estonia, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Rep), Kuwait, Latvia, Lebanon, Libyan Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, Nicaragua, Norway, Occupied Palestinian Territory, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, South Africa, South America, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
Affected count
15,905 units total (5,670 units in US)
Manufactured in
22745 Savi Ranch Pkwy, Yorba Linda, CA, United States
Products
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2015Don't want to check this manually?
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