On December 16, 2013, Covidien sent its customers an Urgent Medical Device Voluntary Field Correction letter regarding the Puritan Bennett 840 Series Ventilator. Customers were instructed to continue using their Puritan Bennett 840 ventilators until they are able to install a software update.
Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death.
The Puritan Bennett 840 Series Ventilator is a critical care ventilator that provides continuous ventilation for infant, pediatric, and adult patients. It was sold by Covidien of Boulder, Colorado, from August 1, 2008, to October 31, 2010.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Announcement