Events

Alerta De Seguridad para Anesthesia Machine ARKON

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 Spacelabs Healtcare Inc || Spacelabs Healthcare 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
    A1702-65
  • Número del evento
    2014EBC-0011550
  • Fecha
    2017-02-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=100
  • 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 possibility of failure in the power source that provides electricity to the subsystems of the equipment, this failure makes the system support its power in the internal batteries without charging them, providing the user with the messages in the "on battery" screen, a once the batteries reach their minimum level of charge, the equipment will be switched off and the corresponding acoustic alarm will be activated, leading to possible serious events on the patients.

Device

Anesthesia Machine ARKON
  • Modelo / Serial
  • Descripción del producto
    The ARKON anesthesia workstation by SPACELABS is designed to be used in hospital environments and operating theaters. It can be used to supply oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits, with or without the use of a ventilator, and can be used to administer vaporasthesic using a removable vaporizer.
  • Manufacturer
    Spacelabs Healtcare Inc || Spacelabs Healthcare Ltd

Manufacturer

Spacelabs Healtcare Inc || Spacelabs Healthcare Ltd