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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Puritan Bennett 980 (PB980) Series Ventilator System see related information
Date Initiated by Firm November 04, 2021
Create Date December 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-0345-2022
Recall Event ID 88987
510(K)Number K193056  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 Series Ventilator,980X1ENAIQC
Code Information GTIN/UDI - 10884521171787 Serial Numbers: 35B1703376
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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