Events

Safety Alert for Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 and 10216710291, risk class III, serial numbers affected (SEE ANNEX).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; 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
    1808
  • Date
    2016-01-21
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Philips will shortly release the updated device software to avoid the problem described above. Updated device software will be available at my.respironics.com. Customers of this product will receive a letter stating the availability of the updated software. /// The registry holder has been reinforced by the need for users to verify the correct prescription for their therapy session, displayed in the upper left corner of the Trilogy screen.
  • Reason
    Philips respironics has learned that trilogy fans, with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01, are susceptible to an accidental change in prescriptions. this can occur under a certain set of operating conditions and after a specific sequence of keystrokes without requiring the user to confirm the change. the devices continue to display precisely the active prescription in the upper left corner of the screen. since this change in prescription was accidental and no confirmation was required, the user may not have noticed this change.
  • Action
    Field Correction by releasing the updated software from the device to avoid the problem described above. The updated device software will be available at my.respironics.com //// Recommendations to users and patients: 1. Complete and return the Business Response Form. 2. Affected devices may continue to be used in accordance with the Device Instructions for Use and this Safety Notice. 3. Notify users with affected devices of the following: - Check the correct prescription for your therapy session, displayed in the upper left corner of the Trilogy 4 screen. In accordance with your usual operating procedures and / or maintenance schedule, update the device software as it becomes available. (Field Action: FSNR-01-2016-A)

Device

Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 an...

Manufacturer

Philips Medical Systems Ltda.; Respironics, Inc.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA