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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Puritan Bennett 980 (PB980) Ventilator Series System see related information
Date Initiated by Firm November 04, 2021
Create Date December 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-0347-2022
Recall Event ID 88987
510(K)Number K193056  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Code Information GTIN/UDI - 10884521171541 Serial Numbers: 35B1700300 35B1700306 35B1700307 35B1700362 35B1700372 35B1700384 35B1700387 35B1700388 35B1700396 35B1700397 35B1700403 35B1700413 35B1700416 35B1700418 35B1700426 35B1700431 35B1700434 35B1700440 35B1700445 35B1700451 35B1700452 35B1700453 35B1700459 35B1700461 35B1700464 35B1700468 35B1700472 35B1700477 35B1700478 35B1700479 35B1700480 35B1700484 35B1700485 35B1700494 35B1700495 35B1700496 35B1700501 35B1700502 35B1700503 35B1700504 35B1700534 35B1700574 35B1700579 35B1700604 35B1700609 35B1700638 35B1700655 35B1700664 35B1700816 35B1700919 35B1700994 35B1701001 35B1701418 35B1701698 35B1702832 35B1703438 35B1800033 35B1800721 35B1800811
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Technical Service
800-255-6774
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 2		 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Covidien, LLC
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