Poor Wire Insulation Prompts Infant Ventilators Recall

Salt Lake City-based Bunnell performed a voluntary Class I recall of Life Pulse high-frequency ventilator patient circuits distributed between March and October 2012. The circuits are used to treat infants with respiratory distress syndrome complicated by pulmonary air leaks who are failing on conventional ventilation. Some of the wire insulation in the recalled units may melt, producing sparks and smoke near the humidifier cartridge. The defect can cause serious adverse events, including death. The recall notice instructs Bunnell customers on steps to take if they feel the circuits are medically necessary.

From hardware to software, anything can cause the FDA to issue a recall. With emerging software applications, how safe is your company’s device?

A recent FDA report found 25 percent of all device recalls were the result of bad software.

Fear not, if you missed the live Medical Device Software Recalls on the Rise What’s Causing Them, What the FDA is Doing About Them, and What Manufacturers Should Do to Prevent Them conference. FDAnews has an audio CD and transcripts available for you to learn from. Find out typical causes of software failures that lead to device recalls and what the FDA is doing to reduce medical device software failure rates.

You might have missed it once, but don’t let it happen again. Order your copy today!