Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Puritan Bennet 980 (PB980) Ventilator Series Systemsee related information
Date Initiated by FirmNovember 04, 2021
Date PostedDecember 09, 2021
Recall Status1 Terminated 3 on July 09, 2024
Recall NumberZ-0339-2022
Recall Event ID 88987
510(K)NumberK193056 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductPuritan Bennett 980 Series Ventilator, 980A3ENNISB
Code Information GTIN/UDI - 10884521201910 Serial Numbers: 35B1700246, 35B1700543, 35B1700887
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactTechnical 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 2		Reprocessing Controls
ActionOn 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 Commerce278 total
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
-
-