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Class 2 Device Recall Puritan Bennett 840 Series Ventilator Date Initiated by Firm January 25, 2013 Date Posted January 24, 2014 Recall Status Terminated on November 24, 2014 Recall Number Z-0821-2014 Recall Event ID 510(K)Number Product Classification - Product Code 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 CO For Additional Information Contact Mr. 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 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. 2010 mitsubishi lancer sportback gts. 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.

840 Ventilator Parts

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.

840 Ventilator For Sale

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.