Alerta De Seguridad para Anesthesia System Anesthesia System Anesthesia System ANVISA Registration Number: 80071260356 Hazard Class: III Affected Model: Carestation 620, Carestation 650 and Carestation 650c Series numbers affected: Models Carestation 620, Carestation 650 and Carestation 650c with software version Revision.01

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.

The following actions are recommended: Instructions for Problem No. 1: If the FiCO2 value can not be adequately reduced with this action, consider moving to another anesthesia device. GE Healthcare recommends the use of a CO2 monitor whenever anesthesia is delivered according to the advice contained in our user reference manuals: European, international and national standards require that the following monitoring be used with this system: - Expired volume monitoring. - O2 monitoring. - Monitoring of CO2. - Anesthetic agent monitoring should be used when anesthetic vaporizers are in use. Instructions for Problem No. 2: If this unexpected transition to a system malfunction occurs: - Manually ventilate the patient (move bag switch to ventilate bag position, adjust APL, increase oxygen flow O2) as needed to fill the manual bag), - Monitor the patient, - Turn off and on the system power by pressing the power switch for 5 seconds twice to perform self-startup tests and restore normal operation. Make sure that the pre-use instructions have been followed. These are included in the Device User Reference Manual and Integrated System Verification of the device and instruct the user to verify that the backup ventilation method, independent of the anesthesia machine, is available and functional prior to use.