Safety Alert for Invasive and Non-Invasive Ventilation System ASTRAL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Resmed-Duncan Distribution Center || Resmed Germany Inc || Resmed Corp || Resmed Ltd || Resmed Paris || Resmed West Coast Warehouse || Resmed Asia Operations Pty 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
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 states that the fans can not experience a problem when powered by an external battery (external battery astral or rps ii), after 15 minutes of inactivity in stand-by mode the device will automatically turn off and can not be placed again, which can lead to the occurrence of potentially serious adverse events on the patient.