CareFusion has initiated a recall of Avea ventilators in response to a potential malfunction of an AVEA ventilator-specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.
The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. A list of affected model and serial numbers is available at the CareFusion website, link provided below.
The company has notified customers of the recall with an urgent recall letter.
The AVEA ventilator is only used in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients.
Sign Up For A Free 30-Day Trial of StayAlert >>
