The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
This recall has been terminated (originally issued July 15, 2015).
- Recall Initiated
- March 2, 2015
- Posted
- July 15, 2015
- Terminated
- April 29, 2016
- Recall Number
- Z-2083-2015
- Quantity
- 104 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand and United Arab Emirates.
Lot / Code Info
Device Part number: 66 79 847 Serial Numbers: 4, 14-24, 26-29, 31, 37, 40, 56, 138, 199, 205, 367, 369-372, 391, 394-395, 416, 466-491, 517, 519, 525, 567-568, 570, 582-583, 606, 613, 619, 627, 629-631, 633, 635-641, and 643-665
Root Cause
Under Investigation by firm
Action Taken
Maquet sent an Urgent Medical Device Field Action Removal and Replacement Form/Device Removal Response Form dated March 2, 2015 to their affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed read through the letter and inform all members of their staff who may use the affected device. Fill out the attached Device Removal Response Form with requested information, sign and date and fax/email the Response Form using the fax/email information provided. Customers with questions were instructed to contact their Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (press option 3, followed by option 1 and then optionn 1 again.