Covidien Ventilator Recall Issued Due to Risk of Shut Down, Death

A class I recall has been issued for some Covidien ventilators, due to a potential software glitch that may have very serious consequences, causing ventilators to suddenly stop working, which may cause critically ill individuals to suffer serious injury or death.

A Covidien Puritan Bennett 840 Series Ventilator recall was announced by the FDA last week, designating the action as the most serious category of medical device recall due to the risks associated with continued used of the ventilators.

Covidien sent an Urgent Medical Device Voluntary Field Correction letter on December 16, indicating that the machines have a software glitch that could cause them to power down unexpectedly.

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The Covidien Puritan Bennett 840 Series Ventilator is used on critically ill adults, children and infants who cannot breathe on their own without a ventilator. If the device suddenly shuts down, these patients who are unable to breathe without a ventilator could be at risk of oxygen loss or even death.

The FDA recall identified the software problem under diagnostic code “XB0069.” The code may be unexpectedly triggered causing the ventilator to stop functioning altogether. In the event of an XB0069 code, the ventilators safety alarm would also be triggered and require the patient to breathe independently. Due to the serious nature of the risk associated with continued use of the ventilators, the FDA has labeled the problem as a Class I recall, which is reserved for situations where a medical device has the potential to cause very serious harm or result in death.

The recall affects Puritan Bennett 840 Series Ventilators with Software Part Number 4-070212-85, Revision AB-AG. The affected ventilators were manufactured April 30, 1998, to March 12, 2010, and distributed between August 1, 2008, and October 31, 2010.

The Field Correction Letter issued by Covidien notified all affected customers of the problem, the product in question, and any suggested action to be taken. Customers were instructed to continue using the device until they were able to update the software.

A software update for affected units can be done by visiting the software update management portal at www.PB840technicalupdate.com. Customers can follow the online instructions to register and obtain the correct software to prevent any unexpected problems with the machine. There have been no deaths reported in association with this recall. Customers with questions can contact Covidien by calling Covidien Technical Services at (800) 255-6774.

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