Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Recall
- Recall Number
- Z-0691-2016
- Event Number
- 72914
- Firm
- Draeger Medical, Inc.
- FEI Number
- 2517967
- Product Code
- CBK
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 22, 2015
- Posted
- February 3, 2016
- Terminated
- April 5, 2017
- Address
- 3135 Quarry Rd, Telford, PA, 18969-1042
Description
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
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.
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 Drger Oxylog ventilator please contact DrgerService 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.
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.
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