Class 1 Device Recall Emergency Transport Ventilator

• Date Initiated by Firm: December 22, 2015
• Date Posted: February 03, 2016
• Recall Status: Terminated on April 05, 2017
• Recall Number: Z-0691-2016
• Recall Event ID: 72914
• 510(K)Number: K082600 K062267 K103625
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Emergency Transport Ventilator; Oxylog 2000 Plus Ventilator; Catalog Number: 5705080.; ; Volume controlled emergency and transport ventilator with pressure support.
• Code Information: All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: 215-721-5400
• Manufacturer Reason for Recall: Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
• FDA Determined Cause: Device Design
• Action: The firm, Draeger Medical, Inc., sent an "Urgent Medical Device Recall" letter dated 12/21/2015 and a copy of the Instructions for Use (IFU) Supplement to consignees in a method that confirms delivery. The letter described the product, problem and actions to be taken. The consignees were instructed to include a copy of the supplement with their Oxylog IFU; inform all affected users in their facility; and contact Draeger Customer Support at 1-800-543-5047 (press 4 at the prompt) to obtain additional copies of the IFU Supplement Free of Charge. If there are any questions regarding this letter, please contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger Oxylog ventilator please contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt). On 12/09/2016, Draeger mailed an Urgent Medical Device Recall notification letter to affected customers to inform them of a revised new software for the Oxlog 3000/3000plus (version 1.06 for Oxylog 3000 plus and version 1.23 for Oxylog 3000) that reduces the impact of the error condition. Customers will be contacted by a Drager Service Representative to schedule a time to perform the software update free of charge. The new software changes the device behavior in the event of the error (a controller failure). With the new software, in the event of a controller failure, ventilation will not stop. The device will continue to ventilate with the last setting. An alarm will annunciate and be displayed, alerting the user of the controller failure.
• Quantity in Commerce: 0
• Distribution: Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
• 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 = DRAEGER MEDICAL B.V.; 510(K)s with Product Code = CBK and Original Applicant = Draeger Medical Systems, Inc.; 510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL B.V.