Trilogy Evo Platform of Ventilators Medical Device Correction

Providing patients with safe and high-quality therapy devices is our top priority. A mandatory software update (version 1.05.10.00) is now available to resolve safety issues previously communicated.

This software update as well as a user manual addendum will also address other issues.

Please note: Software version 1.05.10.00 is mandatory and supersedes all previous software updates. Corrections addressed in previous versions are also included in this software update.

What does this software update address?

Labeling updates

What do customers need to do?

Questions and answers

What does this software update address?

Previously-communicated issues

Accuracy of Oxygen Delivery (2022-CC-SRC-049)

Product(s) affected: Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal

Originally communicated March 2023

Battery Depleted or Loss of Power Alarms Triggered (2024-CC-SRC-001)

Product(s) affected: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal

Originally communicated February 2024

New non safety-related issues

Flow sensor reading compensation
Software alarm errors
Miscellaneous updates

Labeling updates

Philips Respironics is also addressing labeling updates available via a User Manual addendum. All affected customers will receive this addendum via postal mail.

This addendum will address the following issues:

Ozone-based disinfection method

Products affected: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal
Not previously communicated

Incomplete Contraindications Statement (2023-CC-SRC-011)

Products affected: Trilogy Evo, Trilogy Evo O2, and EV300

Originally communicated November 2023

Translation errors in the Korean, Traditional Chinese, and Spanish Instructions for Use (IFU) manuals (2023-CC-SRC-006)

Products affected: Trilogy Evo, Trilogy Evo O2, and Trilogy EV300

Originally communicated May 2023 for Korean translations.

Please note that incorrect Traditional Chinese and Spanish translations were identified following the initial communication.

Environmental Contamination of Device Sensor (2023-CC-SRC-003)

Product(s) affected: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal

Originally communicated April 2023

What do customers need to do?

1 Download the latest mandatory software update.

View installation instructions

2 Review Updated Trilogy Evo Medical Device Correction for a summary of both new and previously-communicated issues.

View/download

3 Affected customers should complete and return the acknowledgement form contained within the Updated Trilogy Evo Medical Device Correction provided via postal mail.

If you have not yet received the Medical Device Correction via postal mail, please contact your local Philips Respironics Sales Representative or Philips Respironics Customer Service at 1 (800) 345-6443 for homecare customers or 1 (800) 722-9377 for hospital customers.

Questions and answers

Why is Philips Respironics releasing the July 3, 2024 Updated Trilogy Evo Medical Device Correction?

Why is Philips Respironics releasing the July 3, 2024 Updated Trilogy Evo Medical Device Correction?

The purpose of the letter is to inform our customers of the release of a mandatory software update that resolves the safety issues previously communicated as well as a release of a user manual addendum for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and the Trilogy EV300 ventilators. Those previously-communicated issues are summarized within the letter.

In addition, Philips Respironics is taking the opportunity of the software update and User Manual addendum described in this communication to also address additional non-safety related issues which have not previously been conveyed to the market.
I've already been notified of some of these issues. Which form(s) should I complete?

I've already been notified of some of these issues. Which form(s) should I complete?

Please complete the acknowledgement form contained in the Updated Trilogy Evo Medical Device Correction that you received via postal mail dated 7/3/2024 and return to Philips Respironics, even if you have completed the form(s) and have acknowledged these issues in the past.
Does the Updated Trilogy Evo Medical Device Correction introduce any new patient safety issues?

Does the Updated Trilogy Evo Medical Device Correction introduce any new patient safety issues?

No – All patient-safety related issues have been previously communicated. The new issues introduced in the Updated Trilogy Evo Medical Device Correction do not present any new risks or hazards to patients.
I have a question about something else related to this issue

I have a question about something else related to this issue

For further information or support concerning this issue, please contact your local Philips Respironics Sales Representative or Philips Respironics Customer Service at 1 (800) 345-6443 for homecare customers or 1 (800) 722-9377 for hospital customers.