  |
Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed
AUDIENCE: Risk Manager, Surgery, Critical Care Medicine, Nursing, Pediatrics
ISSUE: When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen can result in possible injury or death. See the Recall Notice for a list of part and lot numbers.
BACKGROUND: The Puritan Bennett 980 (PB980) Ventilator System provides constant breathing support for adults, children, and premature babies weighing at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.
RECOMMENDATION: On July 17, 2015, Covidien sent an Urgent: Field Corrective Action Notice to customers informing them that Covidien intends to implement a software update to correct the error. Service engineers will contact customers to help coordinate this process. Until the update is implemented, Covidien recommends the following:
- Assess all neonatal patients on a PB980 ventilator using VC+ in NeoMode to ensure each patient is receiving sufficient ventilation.
- Transfer patients to an alternative ventilator when the patient is clinically stable. Patients can remain on PB980 ventilators until it is safe to transfer them to a different ventilator.
- Immediately notify all users of the PB980 ventilator with the NeoMode feature about this action.
- If the PB980 ventilator is being used with the NeoMode feature in only pressure control modes, transfer the patient to another ventilator as soon as possible.
- Universal model ventilators being used for adult or pediatric patients may remain in use until it is safe to remove the ventilator from use and change the configuration to disable the NeoMode feature.
- Notify any users who the PB980 ventilator was distributed to.
- Complete the form attached to the notice and return it to Covidien.
- Work with Covidien System Engineers to allow them to update the ventilator to remove NeoMode software from the system.
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
- 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.
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 |  |
