Alerta De Seguridad para 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)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; Ge Medical Systems (China) CO., LTD.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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. (...) "
  • Causa
    Ge healthcare recently became aware that an incomplete fence may exist between the co2 absorber and the co2 breathing circuit contour door assembly of the carestation 600 series systems. this incomplete sealing may allow re-inhalation of patient gases that bypass co2 absorbent material and may result in unintentionally inspired high levels of co2 (fico), which may lead to hypercarbia. there were no injuries reported as a result of this problem.
  • Acción
    Field Action Code FMI 34086 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. It will make Correction in the field.