Alerta De Seguridad para Commercial Name: Anesthesia System and Anesthesia Equipment Technical Name: Anesthesia System Advance and Anesthesia Equipment Advance CS2 Registration Number ANVISA: 80071260227 Hazard Class: III Model Affected: Anesthesia System Advance and Anesthesia Equipment Advance CS2 Serial Numbers affected: All Anesthesia Systems Advance. Aespire systems are not affected.

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.; DATEX OHMEDA, INC.

¿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
    You can continue to use your Advance CS2 devices after removing the optional large tray insert if installed. The optional large tray insert can be removed from the device manually by any clinical user or authorized local personnel. No tools and or technical training are required to remove the large tray insert. Avance CS2 and Advance anesthesia devices with optional large insert tray insert (part number 1009-3260-000) are susceptible to the problem. The large tray insert accessory can also be used in the Aespire family of devices, but the Aespire devices are not susceptible to this problem. Inserting an optional small tray does not produce this problem. GE Healthcare requests clinical users who have received this device patch warning to destroy all large-tray inserts in their possession. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Causa
    The machine can be switched to system misalignment if the lower storage drawer containing the optional large tray insert is closed too tightly. when the equipment is switched to malfunctioning, it will automatically activate alternate oxygen flow, provide high-visibility and audible alarms, provide on-screen instructions to set the oxygen flow, and manually ventilate the patient, and continue providing an anesthetic agent in the definition of the existing vaporizer. if the malfunction of the system is considered unresolved, this may result in loss of possible patient ventilation, resulting in hypoxia.
  • Acción
    Field Action Code IMF 34079 triggered under the responsibility of the company GE Healthcare do Brasil, Com. for Equipos Médico-Hospitalares Ltda. Company will deliver letter of Urgent Security Notice