Medical Device Safety and Recalls: Nellcor Puritan Bennett, 980 Ventilator System

A recall has been issued for the Nellcor Puritan Bennett, 980 Ventilator System.  Part of the circuit board may have cracks due to problems in this manufacturing process. The cracks can cause the ventilator’s display screen to dim and give off a burning smell. There is no risk of fire due to this issue, but the part needs to be replaced so information on the display screen will be visible.

The firm received 6 reports of illness or injury and 7 reports due to this problem. These events resulted in emergency responses with the unexpected need to stop the ventilator and transfer the patient to another ventilator.

Being immediately removed from the defective ventilator and changing to another ventilator or a different form of breathing support may lead to a rapid and sudden change in a critically ill patient’s condition and may result in serious injury or death.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm428521.htm


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