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.
Recall
- Recall Number
- Z-1609-2015
- Event Number
- 70920
- Firm
- Carefusion 211 Inc dba Carefusion
- FEI Number
- 3013421741
- Product Code
- CBK
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 3, 2015
- Posted
- May 26, 2015
- Terminated
- July 23, 2018
- Address
- 22745 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4668
Description
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.
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.
A customer letter dated 4/21/15 will be sent to all customers who received the AVEA Ventilator, all models, to inform them that CareFusion has identified a potential risk associated with AVEA Ventilator caused by a malfunction of a pressure transducer. The malfunctioning pressure transducer is detected and by design ceases ventilation and opens the safety valve to atmosphere allowing spontaneous breathing of patients capable of doing so. The non-breathing patient would need to be manually ventilated. The letter informs the customers of the issues, the potential risk, and the actions to be taken. Customers are instructed to contact CareFusion Recall Support Center at (888) 562-6018, (858) 617-5300, or email [email protected] for recall related questions. Customers are instructed to contact CareFusion Technical Support/Customer Advocacy at (800) 231-2466, (714) 283-2228, or email [email protected] for Product Technical Support Adverse Event Reporting. CareFusion posted a press release on their website on 5/27/15 and it was sent to PRNewswire. The press release provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators. The press release provide the problems and the actions to be taken. The press also list the countries that are affected by the recall.
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.
15,905 units total (5,670 units in US)