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.
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.
- AVEA Standard with Compressor ventilator-refurbished (Product number (PN): R17312-xx (xx = 0-14)), AVEA Comprehensive ventilator (PN: 17310-xx (xx = 0-14)), AVEA Standard ventilator (PN: 17311-xx (xx = 0-14)), AVEA Standard with Compressor ventilator (PN: 17312-xx (xx = 0-14)), AVEA Comprehensive ventilator-refurbished (PN: R17310-xx (xx = 0-14)), AVEA Standard ventilator-refurbished (PN: R17311-xx (xx = 0-14)), AVEA Standard with Compressor ventilator-refurbished (PN: R17312-xx (xx = 0-14)), TCA Board (PN: 16542A), GDE- 1st Generation (PN: 16222-001-99), GDE (PN: 16650A), GDE-refurbished (PN: R16650A), AVEA GDE/UIM upgrade kit (PN: 12283-PMN)
- 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
Who May be Affected
- Health care providers using AVEA ventilators
- All patient groups who may be using these ventilator systems for breathing support
What to Do
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
- Report adverse events or quality problems experienced with use of the product to the FDA through:
- MedWatch Online
- Phone: 800-FDA-1088
Health care professionals and consumers with questions are instructed to contact CareFusion at 888-526-6018 or email@example.com with any questions related to this recall.
Date Recall Initiated:
May 17, 2016
How to Report a Problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.