Safety Alert for Anesthesia System Anesthesia System ANVISA Registration Number: 80259110040 Hazard Class: III - High Risk Affected Model: FLOW-i C20, FLOW-i C30, FLOW-i C40 Affected serial numbers : 2781; 4261; 4262; 4263

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Field action consists of replacing all affected PC Cards in the installed base. This Field Security Notification is only applicable until the FLOW-i system has been updated with the replacement of the PC Cards. WARNING: If the malfunction occurs during operation, activate the built-in emergency ventilation and switch to an alternative anesthesia system or anesthesia method. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link #### UPDATED ON 09/4/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.