Class 1 Device Recall Puritan Bennett 980 (PB980) Ventilator Series System

• Date Initiated by Firm: November 04, 2021
• Date Posted: December 09, 2021
• Recall Status: Terminated on July 09, 2024
• Recall Number: Z-0349-2022
• Recall Event ID: 88987
• 510(K)Number: K193056
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
• Code Information: GTIN/UDI - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Technical Service; 508-261-8000
• Manufacturer Reason for Recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
• FDA Determined Cause: Reprocessing Controls
• Action: On November 4, 2021, the firm began to notify customers through Urgent Medical Device Correction letters. Customers were informed of the device defect that may lead to the ventilator becoming inoperable during use. Actions you should take Immediately discontinue use of the affected ventilators. Remove the affected ventilators from clinical service and quarantine the affected ventilators until such time that a Medtronic Technical Service Engineer inspects and replaces the affected printed circuit board assemblies. Notify all personnel in all care environments in which the affected PB980 series ventilators are used about this medical device correction. If your facility has distributed affected PB980 series ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. If you are aware of any incidents related to this issue, please contact our Technical Support Department immediately at 1-800-255-6774, option 4, and then option 1 to provide information regarding those events so regulatory reporting obligations can be fulfilled. Work with the Medtronic Technical Support Department if you require assistance finding alternative ventilation devices. Beginning November 5, 2021, Medtronic Technical Service will contact all affected customers to schedule a service appointment for all potentially affected ventilators. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.
• Quantity in Commerce: 278 total
• Distribution: Worldwide distribution - US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK