Events

Alerta De Seguridad para Anesthesia system Flow-I

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por 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
    I1603-124
  • Número del evento
    2011EBC-0008130
  • Fecha
    2016-03-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected the generation of the alarm te63 / 64 (with error code 201) during some circumstances, when the biomedical equipment interprets that the internal communication does not work as expected, this false alarm causes the vaporizer to be deactivated due to timing issues between two subsystems, leading to the potential occurrence of adverse events on patients.

Device

Anesthesia system Flow-I
  • Modelo / Serial
    FLOW ANESTHESIA SYSTEM - I - MAQUET, software versions 4.1.
  • Descripción del producto
    Intended for the administration of anesthesia while controlling the complete ventilation of patients with no ability to breathe, as well as in the support of patients with limited ability to breathe.
  • Manufacturer
    Maquet Critical Care AB

Manufacturer

Maquet Critical Care AB
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NIDFSINVIMA