On July 28, 2016, the FDA has classified CareFusion’s recall of its AVEA ventilator as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
On May 17, 2016, CareFusion recalled the AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen.
The AVEA ventilator is intended for continuous breathing support for infants, children, and adults. The ventilator is only used in hospitals and other health care facilities.
Recalled ventilators were manufactured from November 13, 2016, to January 4, 2016. Recalled ventilators were distributed from December 16, 2016, to February 15, 2016. Over five hundred units were distributed nationwide.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe