Class 1 Recall: Nellcor Puritan Bennett, 980 Ventilator System - Component Failure May Cause Burning Odor
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
Wed Oct 01 2014
Recall Class: Class I
Date Recall Initiated: October 1, 2014
Devices: Puritan Bennett 980 Ventilator
- Manufacturing Dates: March 3, 2014 through August 19, 2014
- Distribution Dates: March 3, 2014 through August 22, 2014
See list of recalled serial numbers.
Use: The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and premature babies that weigh at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.
Recalling Firm:
Nellcor Puritan Bennett Inc. (doing business as Covidien LP)
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214
Reason for Recall: 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.