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U.S. Department of Health and Human Services

Class 1 Device Recall Puritan Bennett 980 Ventilator System Universal and Neonatal Models

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  Class 1 Device Recall Puritan Bennett 980 Ventilator System Universal and Neonatal Models see related information
Date Initiated by Firm July 16, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on June 02, 2016
Recall Number Z-2329-2015
Recall Event ID 71675
510(K)Number K131252  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models.

Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
Code Information PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS
Recalling Firm/
Manufacturer		 Covidien LP (formerly Nellcor Puritan Bennett Inc.)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact Michael A. Ronningen
303-876-8870
Manufacturer Reason
for Recall		 Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
FDA Determined
Cause 2		 Software design
Action Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.
Quantity in Commerce 657 units
Distribution Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
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 and Original Applicant = COVIDIEN
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