FDA MedWatch - AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown

AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown

AUDIENCE: Risk Manager, Nursing, Critical Care Medicine

ISSUE: CareFusion is recalling 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 use of affected product may cause serious adverse health consequences, including death.

• Manufacturing Dates: November 13, 2016 to January 4, 2016
• Distribution Dates: to December 16, 2016 to February 15, 2016
• Devices Recalled in the U.S.: 501 units distributed nationwide

See the Recall Notice for a listing of affected product numbers.

BACKGROUND: 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.

RECOMMENDATION: On May 17, 2016, CareFusion sent a “Field Safety Notice” letter to affected health care facilities. The letter instructed health care professionals and consumers to:

• Complete and return the acknowledgement and receipt form
• After the response card is returned, CareFusion will schedule onsite remediation for affected devices
• Identify and remove affected ventilators as instructed in CareFusion’s Field Safety Notice

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm513810.htm

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