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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan Bennett 840 Series Ventilator

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 Class 2 Recall
Puritan Bennett 840 Series Ventilator
see related information
Date Posted January 24, 2014
Recall Status1 Terminated on November 24, 2014
Recall Number Z-0821-2014
Recall Event ID 67163
Premarket Notification
510(K) Numbers
K964540  K970460  K984379  K990897 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
Code Information PB840 Operators Manual Addendum: PN 066009A 09/02
Recalling Firm/
Manufacturer
Nellcor Puritan Bennett Inc. (dba Covidien LP)
6135 Gunbarrel Ave
Boulder, Colorado 80301-3214
For Additional Information Contact Mr. Michael A. Ronningen
303-876-8870
Manufacturer Reason
for Recall
Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action The firm, Covidien, sent an "URGENT MEDICAL DEVICE VOLUNTARY FIELD CORRECTION" letter dated January 24, 2014 to its Consignees/customers via certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to read and understand the enclosed information; communicate this information to those who need to be aware of this labeling update; for the Puritan Bennett 840 ventilator only: If you have addendum P/N 066009A 09/02, remove and discard the addendum and replace it with the new information in Attachment I; for the Puritan Bennett 740 and 760 ventilators only: Add the new information in Attachment I; Ensure all O2 sensors in use or in inventory conform to the instructions in this notification. to your current operators manual and service manual, and read and understand the warnings, cautions and notes related to safety, ventilator use and operation that are contained in the Preface of the Operators Manuals. are asked to remove incorrect labeling and replace with the revised labeling. Covidien enclosed a labeling update (Attachment I) which provides detailed information related to the life of oxygen sensors used with the Puritan Bennett 840, 740 and 760 ventilators. Covidien has validated another oxygen sensor, P/N 10097559, for use in the Puritan Bennett 840, 740 and 760 ventilators. Information about that sensor is also included in the update in Attachment I. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840, 740 or 760 ventilators contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed.
Quantity in Commerce 70,160
Distribution Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PURITAN BENNETT CORP.
510(K)s with Product Code = CBK and Original Applicant = PURITAN-BENNETT IRELAND, LTD.
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