FDA Class I Recall for Covidien Puritan Bennett 840 Series Ventilators

covidien-puritan-ventilators-recallA software problem that could cause the Covidien Puritan Bennett 840 Series Ventilators to stop functioning, leaving critically ill patients to breathe on their own, has prompted a recall of the ventilators.

The Food and Drug Administration announced the recall on its website in December.  This is a Class I recall, which is the agency’s most serious category, reserved for situations where the recalled product may cause serious adverse health consequences, and even death. The FDA announcement says the software problem may trigger a diagnostic code (XB0069) that causes the ventilator to stop functioning. The patient would then need to breathe on his or her own, which critically ill patients may not be able to do. These ventilators are used on patients of all ages, including infants and children.

The ventilators were manufactured by Colorado-based Covidien between April 30, 1998 and March 12, 2010; they were distributed from August 1, 2008 to October 31, 2010.

On December 16, 2013, the company sent customers an Urgent Medical Device Voluntary Field Correction letter with instructions for how to install the software update outlined in the letter. Customers may register at the software update management portal at www.PB840technicalupdate.com and follow the instructions for the software update.

For questions about the recall, call Covidien Technical Services at 1.800.255.6774, Monday through Friday, from 6 a.m. to 5 p.m. Pacific Time (menu option 4). Customer service (menu option 3) is available Monday through Friday, from 8 a.m. to 6:30 p.m. Eastern Time.

Consumers and health care professionals are encouraged to report adverse reactions or quality problems with these products to the FDA through the MedWatch Adverse Events Reporting system: www.fda.gov/medwatch/report.htm.

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