Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX OHMEDA, INC..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2285
  • Date
    2017-05-11
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Ge healthcare was aware of two problems with caresthetic anesthesia systems. problem 1: incomplete sealing may exist between the disposable absorber and the lower breathing circuit assembly of the carestation 600 series systems. this incomplete sealing may allow re-inhalation of patient gases that have bypassed the carbon dioxide absorbent material ( co2), which can result in high levels of unintentionally inspired co2 (fico2) and lead to hypercarbia. problem 2: an unexpected transition to a system malfunction may occur on carestation 600 series systems. when this occurs, you will see this message displayed on the screen: "internal malfunction of the system prevents normal operation. backup ventilation option.To restart, power cycle and power on again. ".
  • Action
    Field Action Code FMI 34082 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

Anesthesia System Anesthesia System Anesthesia System ANVISA Registration Number: 80071260356 Haz...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX OHMEDA, ...