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FDA classifies CareFusion’s recall of AVEA ventilators as class I recall

Medical technology company CareFusion has announced that the US Food and Drug Administration (FDA) classified the company’s voluntary recall of AVEA ventilators as a class I recall.

On 3 September 2013, the company initiated the voluntary recall of its AVEA ventilators related to barometric pressure sensor compensation when using the neonatal wye hot wire flow sensor.

If used in conjunction with the neonatal hotwire flow sensor, the AVEA ventilators may experience an underreporting of tidal volume due to lack of barometric pressure sensor compensation and the patient may receive a higher tidal volume than expected.

According to the company, hospitals in locations at higher than 5,000ft above sea level that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error as the level of underreporting between displayed flow and actual flow increases proportionately with altitude.

The company received five complaints from a neonatal patient care settings facility, which is located higher than 5,000ft above sea level.

CareFusion had notified the FDA on this recall.

A class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.