Regulatory Focus™ > News Articles > Breaking Device: Too-High Device at Risk of Breakdown, Says Company

Breaking Device: Too-High Device at Risk of Breakdown, Says Company

Posted 30 September 2013 | By Alexander GaffneyRF News Editor

Amongst the long list of reasons for medical device product recalls-manufacturing mishaps, faulty designs, programming errors-few seem as odd as the reason behind a recall initiated on 27 September 2013: The Colorado Rockies exist.

Well, maybe not the Rockies, per se, but the rationale behind Carfusion's Class 1 recall for its Avea Ventilator product is pretty much the same.

In the voluntary recall notice posted on the US Food and Drug Administration's (FDA) website, the company explains that it is initiating the recall because it had identified a "potential risk" when the ventilator is used at high altitudes.

"A proactive complaint review identified an error in the barometric pressure compensation," the firm wrote.

In its recall letter to physicians, Carefusion elaborated further, saying the devices could underreport the tidal volume present in the device when used in conjunction with a flow sensor. The errors can exist at any altitude in excess of 5,000 feet above sea level, the company said. In other words, almost the exact elevation of Denver, Colorado-the "Mile High" city.

The recall was first communicated to its customers on 3 September 2013, and reportedly affects 19,546 units worldwide.


Recall Notice


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