Events

Safety Alert for unkown device

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

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
    I1601-23
  • Event Number
    2009EBC-0004309
  • Date
    2016-01-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • 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 referenced devices support dual therapy prescriptions, and two prescriptions could be programmed by a healthcare professional specific to the patient's needs prescribed by the physician, this can occur under a particular set of operational conditions and after a specific sequence of combination of keys without requiring confirmation of the change by the user.

Device

unkown device
  • Model / Serial
    TRILOGY 100 and TRILOGY 200, with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01
  • Product Description
    This unit can facilitate non-invasive or invasive ventilation. It can be used to provide patients with total ventilation therapy as they progress from a non-invasive to invasive mode.
  • Manufacturer
    Respironics Inc (Sleep Therapy)

Manufacturer

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