Alerta De Seguridad para Name: Anesthesia System Carestation. Technical Name: Anesthesia Device. ANVISA registration number: 80071260222. Class of risk: III. Model affected: All. Serial numbers affected: 9100c (ANVISA Register 80071260222)

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
    The user can continue to use the system. If the user notices a malfunction of the display before using it on a patient, the power must be restarted to solve the problem. If the user notices a malfunction of the display during use, the manual balloon must be selected using it to switch the ventilation. At any time the clinician may use a self-inflating balloon to ventilate the patient and / or to switch to another anesthesia device, so severity can be classified as SERIOUS. If this problem occurs on the display of the anesthesia device during use, the device will continue to ventilate, provide anesthetic agent, provide alarms and will display a "Shutdown Mode, contact your GE authorized service engineer, use the Bag, CSB and DMB Communication Failure mode, alerting the clinician about a problem with the device. The clinician may switch the patient to another anesthesia device and continue using the current device without the display until the pre-use check and parameter settings on the new anesthesia device are completed. Alternatively, the clinician may switch to using a self-inflating balloon for manual ventilation for as long as a new anesthetic device is ready. When using a self-inflating balloon, the clinician would need to use intravenous anesthetics to ensure adequate anesthesia. If the problem occurs before the case, the clinician can cycle to solve the problem. Therefore, it is rare that loss of the primary ventilator parameters that may result from screen shutdown would result in serious injury to the patient. The loss of user interface is immediately obvious. The fan continues to operate in previously set configurations. Good clinical practices of patient and ventilator monitoring will avoid adverse outcomes, so the likelihood of the event occurring is REMOTE. 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 Additional information: - Date of identification of the problem by the company: 11/10/2017 - Date of notification notice to Anvisa: 01/24/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. 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
    There is an unexpected device malfunction involving loss of communication between the control sample board and the monitor display board during use. this issue will prevent the clinician from adjusting the ventilation parameters on the display and could cause reversible, nonfatal changes in clinical status if the clinician can not change these settings. the system will continue to ventilate the patient and monitor the parameters with audio alarms available during these faults. mechanical and manual ventilation modes will continue to be available in this situation. there were no injuries reported as a result of this problem.
  • Acción
    Field Action Code IMF 34089 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Will perform field correction.