Alerte De Sécurité sur Name: Anesthesia System Carestation. Technical Name: Anesthesia Device. ANVISA registration number: 80071260356. Class of risk: III. Affected Model: Carestation 620, Carestation 650, Carestation 650C. Affected serial numbers: Carestation 620, Carestation 650, Carestation 650C (ANVISA Register 80071260356)

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.

If the user notices high FiCO2, increase the fresh gas flow to reduce the gas volume of the patient being re-inhaled. If FiCO2 can not be adequately reduced with this action, consider switching to another anesthesia delivery device. GE Healthcare recommends the use of CO2 monitor whenever anesthesia is being provided. According to the advice contained in the user reference manual, "European, international and national standards require the following monitoring to be used with this system: • Expired volume monitoring. • O2 monitoring. • CO2 monitoring. • Anesthesia agent monitoring should be used when anesthetic vaporizers are in use. "If you want 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 In order to access the System, it is necessary to register and select the Health Professional option, if it is a liberal professional or the Institution / Entity option, if it is a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/06/2017 - Date of notification notice to Anvisa: 10/26/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. The company that holds the affected product registration is responsible for timely contacting its customers in order to ensure the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "