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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-0352-2022
Recall Event ID 88987
510(K)Number K193056  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Code Information GTIN/UDI - 10884521172524 Serial Numbers: 35B1700308 35B1700311 35B1700361 35B1700363 35B1700364 35B1700366 35B1700368 35B1700369 35B1700370 35B1700371 35B1700373 35B1700375 35B1700376 35B1700377 35B1700378 35B1700379 35B1700380 35B1700382 35B1700383 35B1700385 35B1700386 35B1700389 35B1700390 35B1700391 35B1700392 35B1700394 35B1700395 35B1700398 35B1700400 35B1700401 35B1700402 35B1700404 35B1700410 35B1700414 35B1700415 35B1700417 35B1700421 35B1700422 35B1700423 35B1700424 35B1700433 35B1700441 35B1700444 35B1700446 35B1700448 35B1700450 35B1700454 35B1700455 35B1700463 35B1700466 35B1700491 35B1700497 35B1700498 35B1700500 35B1700506 35B1700515 35B1700521 35B1700523 35B1700524 35B1700528 35B1700532 35B1700535 35B1700550 35B1700556 35B1700571 35B1700607 35B1700620 35B1700666 35B1700989 35B1701004 35B1701015 35B1701417 35B1701419 35B1702698 35B1702873 35B1703371 35B1703383 35B1703421 35B1800480 35B1800511 35B1800522 35B1800531
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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