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 Paris || Resmed West Coast Warehouse || Resmed Germany Inc || Resmed Ltd || Resmed-Duncan Distribution Center || Resmed Asia Operations Pty Ltd || Resmed Corp.

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
    I1408-343
  • Event Number
    2011DM -0007955
  • Date
    2014-08-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=197
  • 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 and informs that the procedure described in the instructions of the user guide refers to the way of configuring the breathing circuit for impedance measurement and tuning of the fan before they can be misinterpreted by the user, resulting in the pressure delivered by the user. the equipment may be incorrect or the visual pressure does not correspond to the pressure exerted by the equipment, which may lead to adverse events occurring in the patient.

Device

Invasive and non-invasive ventilation system

Manufacturer

Resmed Paris || Resmed West Coast Warehouse || Resmed Germany Inc || Resmed Ltd || Resmed-Duncan ...