Software Glitch In Covidien Ventilator More Serious Than Thought, Could Be Deadly: FDA

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A Covidien field correction of a ventilator with faulty software recently received a Class I designation from the FDA, which means the issue could cause serious adverse health consequences or even death if not corrected.

The software defect involves models of Covidien's Puritan Bennett 840 Series Ventilator manufactured April 30, 1998 to March 12, 2010 and distributed August 1, 2008 to October 31, 2010. The critical care ventilator is used for patients of all ages. Affected models have a software glitch that triggers a diagnostic code that would require patients to have to breathe on their own.

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