Covidien said Monday that its Puritan Bennett 980 ventilator has received CE Mark approval in Europe.The ventilator system, also approved for commercial distribution in the U.S., Japan, and Canada, is expected to go on sale in coming months.

Covidien is billing the Puritan Bennett 980 as "simple, safe, and smart." That should be good news for Covidien if the claims turn out to be true, especially after the serious ventilator recalls the company has seen in recent years.A Covidien field correction of a ventilator with faulty software recently received a Class I designation from the FDA. 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.Last year, Covidien saw another ventilator recall that the FDA considered serious and potentially life-threatening. Covidien recalled some battery packs used with the Newport HT70 ventilator. Under some conditions, the battery may not charge correctly and will automatically revert the unit to its emergency battery backup. This can put patients at an increased risk of adverse events.The new Puritan Bennett 980 boasts safety features including a "ventilation assurance feature" that will allow for continued operation, as close to the preset settings as feasible, should certain system failures take place. There is an additional screen located on the breath delivery unit that provides a redundant check of ventilator operation, and the ventilator houses up to two batteries without a compressor installed.Puritan Bennett ventilators also have an expiratory filtration system meant to protect both patients and care staff from cross contamination.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.