FDA Issues Class I Recall of Certain Ventilators due to Software Problem
On December 16, 2013, the FDA issued a Class I Recall of the Covidien Puritan Bennett™ 840 Series Ventilator due to a software problem. As defined by the FDA, “Class I Recalls are the most serious type of recall and involve situations in which there is reasonable probability that use of these products will cause serious adverse health consequences or death.”
These ventilators are used on critically ill patients who may not be able to continue breathing without the assistance of the ventilator. As a result, this software problem may cause serious adverse health consequences – and even death. The FDA provided the following as the reason for the recall: “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.”
The FDA commented that Covidien, the manufacturer of the product at issue, sent its affected customers an Urgent Medical Device Voluntary Field Correction letter. The letter informed the customers of the problems associated with the product and the actions to be taken by the customers, including instructions to install a particular software update. Covidien also has a webpage for the technical update that is accessible here. In particular, the range of manufacturing and distribution dates for the products at issue are as follows:
- Manufactured: April 30, 1998 – March 12, 2010
- Distributed: August 1, 2008 – October 31, 2010
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