Jan

2014

Class l Puritan Bennett 840 Series Ventilators

Company:Covodien.
Date of Enforcement Report:1/9/2014
Class l:

PRODUCT

Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014

REASON
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.

RECALLING FIRM/MANUFACTURER
Covidien, Boulder, CO 12/16/2013. Voluntary: Firm Initiated recall is ongoing.

FDA District: Denver District

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class l Puritan Bennett 840 Series Ventilators

Amy Sellers

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