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.
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.
Public Contact: For questions about this recall, contact Covidien’s Technical Support Department at 1 (800) 255-6774, option 4, then option 1, Monday through Friday, 6 a.m. to 4 p.m., Pacific Time.
FDA District: Denver District Office
More Information about this Recall:
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.
Important Safety Reminders:
- Always closely watch patients on ventilators.
- Always keep another source of breathing support nearby when using the ventilator.
- Always connect at least two gas sources to the ventilator to make sure a constant gas supply is ready for the patient in case one of the gas sources fails.
- Maintain the ventilator at the suggested times as found in Table 7-1 in the operator’s manual.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.