Events

Safety Alert for Invasive and non-invasive ventilation system

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

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
    A1506-258
  • Event Number
    2011DM-0007955
  • Date
    2015-06-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=177
  • 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 previous fans allow doctors to deactivate all alarms, including those that detect the disconnection of the circuit, it is possible that a disconnection of the circuit that occurs and pass unnoticed may lead to inadequate ventilation and damage to the patient, which may entail to potentially present serious adverse events on the patient.

Device

Invasive and non-invasive ventilation system
  • Model / Serial
    Astral 100 and 150.
  • Product Description
    The stellar ventilation system is designed to provide ventilation to adult and pediatric patients who are not dependent (13 kg / 30 lb or more), who breathe freely and who have partial or total respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or for invasive use with a sleeveless or sleeveless tracheotomy tube. Parauso in the hospital or at home.
  • Manufacturer
    Resmed Inc.

Manufacturer

Resmed Inc.