Events

Alerta De Seguridad para Trade name: Flow-i Anesthesia System; Technical Name: anesthesia machine. ANVISA registration number: 80259110091; Risk class: III; Affected model (s): C20, C30 and C40; and Batch (s) / Serial number (s) affected: Attached document

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA; MAQUET CRITICAL CARE AB.

¿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
    1949
  • Fecha
    2016-06-07
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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 technical alarm generated is a warning device that prompts the user to take measures such as reducing the flow of fresh gas (to keep the anesthetic in the breathing circuit) and / or injecting intravenous medications necessary to ensure sufficient depth of anesthesia. ## UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    The technical alarm generated is a warning that the user is advised to take measures such as reducing the flow of fresh gas (to maintain the anesthetic in the breathing circuit) and / or injecting intravenous medications necessary to ensure sufficient depth of anesthesia.
  • Acción
    Field Action No. MCC / 16/001 / NU triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA. Anesthesia System Software Update.

Device

Trade name: Flow-i Anesthesia System; Technical Name: anesthesia machine. ANVISA registration num...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA; MAQUET CRITICAL CARE AB
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA