www.fdanews.com/articles/142734-fda-issues-medical-device-alert-for-ventilator
FDA Issues Medical Device Alert for Ventilator
December 27, 2011
The Food and Drug Administration (FDA) has issued an alert for CareFusion 211’s AVEA ventilators due to a failure where the device activates a false extended high peak alarm, opens the safety valve and stops ventilating.