Class I Medical Device Recall: CareFusion AVEA Ventilator
Recall Class: Class I
Date Recall Initiated: September 8, 2011
Product: AVEA ventilators manufactured between March 1, 2009 and June 30, 2011.
Use: The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions.
CareFusion 211, Inc.
22745 Savi Ranch Parkway
Yorba Linda, California 92887
Reason for Recall: The AVEA ventilator can develop a failure where the ventilator activates a false Extended High Ppeak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.
CareFusion has received a total of 94 reports of incidents in which the ventilator has apparently malfunctioned. No deaths or injuries were reported.
Public Contact: Affected customers with questions may contact the CareFusion Recall Support Center, toll-free: 1-888-562-6018.
FDA District: Los Angeles
FDA Comments: CareFusion notified customers via recall notice on September 15, 2011 with a follow-up letter on October 4, 2011. The recall notice stated that the CareFusion Recall Support Center is contacting customers to arrange for onsite remediation of the affected devices.
Customers were also instructed to follow these steps if any AVEA ventilator in their facility exhibits a sustained Extended High Ppeak alarm followed by the opening of the safety valve:
- Remove the ventilator from service
- Provide alternate ventilation
- Contact CareFusion Technical Support at 1-800-231-2466 to report the issue
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm either online, by regular mail, by telephone, or by FAX.