Events

Safety Alert for Respironics ventilator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Respironics 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
    R1402-83
  • Event Number
    INVIMA 2009EBC-0004309
  • Date
    2014-02-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • 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
    It is affirmed that the ventilators of the models mentioned commercialized between december 31, 2013 and january 30, 2014, contain a potentially defective ferrite component that could affect the operation of the biomedical equipment, causing a failure in the mechanical ventilation and in the functionality of the alarm that can be reduce only to indicate ventilatory insufficiency, leading to the potential occurrence of adverse events on the patient causing serious deterioration in their health condition or even death.

Device

Respironics ventilator
  • Model / Serial
    TRILOGY 100, 200 and 202
  • Product Description
    This unit can facilitate non-invasive or invasive ventilation. It can be used to provide patients with total ventilation therapy as they move from a noninvasive to an invasive way.
  • Manufacturer
    Respironics Inc

Manufacturer

Respironics Inc
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA