Events

Safety Alert for Anesthesia Machine ARKON

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Spacelabs Healtcare Inc || Spacelabs Healthcare Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    A1702-65
  • Event Number
    2014EBC-0011550
  • Date
    2017-02-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=100
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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