Faulty Fuse Spurs Recall of AVEA Ventilators

CareFusion is recalling its AVEA ventilator because of an electrical issue on the product's alarm board that may cause it to shut down unexpectedly.

CareFusion is recalling its AVEA ventilator because of an electrical issue on the product’s alarm board that may cause it to shut down unexpectedly.

The AVEA ventilator is indicated for continuous breathing support for infants, children, and adults in hospitals and other health care facilities. If the product shuts down, the patient may not receive necessary oxygen, which may result in serious adverse effects, such as death.

The 501 units being recalled were manufactured between November 13, 2015, and January 4, 2016, and they were distributed nationwide between December 16, 2015, and February 15, 2016.

Product Description

Product Numbers

AVEA Standard with Compressor ventilator-refurbished

R17312-xx (xx = 0-14)

AVEA Comprehensive ventilator

17310-xx (xx = 0 -14)

AVEA Standard ventilator

17311-xx (xx = 0 -14)

AVEA Standard with Compressor ventilator

17312-xx (x=0 -14)

AVEA Comprehensive ventilator-refurbished

R17310-xx (xx = 0-14)

AVEA Standard ventilator-refurbished

R17311-xx (xx = 0-14)

AVEA Standard with Compressor ventilator-refurbished

R17312-xx (xx= 0-14)

TCA Board

16542A

GDE- 1st Generation

16222-001-99

GDE

16650A

GDE-refurbished

R16650A

AVEA GDE/UIM upgrade kit

12283-PMN

CareFusion began sending notice letters to affected health care facilities on May 17, 2016. In them, the company noted that a “malfunction creates a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation to the patient. By design, an audible clinical alarm is activated.”

Those who identify the ventilators listed above are advised to complete and return the receipt form that came with their notice letters, as well as remove the affected products. Health care professionals and patients are also encouraged to report adverse events or side effects related to the use of the products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

“We recognize the inconvenience this issue may cause your facility and thank you for your support in this important matter,” CareFusion wrote in its letters.