  |
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor
AUDIENCE: Risk Manager, Critical Care Medicine
ISSUE: Part of the Nellcor Puritan Bennett 980 Ventilator System circuit board may have cracks due to problems in the 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.
Reported 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.
BACKGROUND: 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.
RECOMMENDATION: See the list of recalled serial numbers. Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers with the following information:
- A Covidien representative will replace the backlight inverter PCBA on the ventilators as soon as possible.
- Complete the Field Safety Corrective Action Verification Form enclosed with the letter. Fax it to the Covidien Respiratory & Monitoring Solutions contact as shown on the form.
- Inform others within the facility as required. Send a copy of the Urgent Field Corrective Action letter to other healthcare facilities or individuals who received the Puritan Bennett 980 Ventilator.
For further assistance, contact Covidien’s Technical Service Support Department at 1-800-255-6774, option 4, option 1.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
