Trilogy Evo Platform of Ventilators Medical Device Correction

Philips Respironics has identified two potential issues that could impact patient safety if not mitigated. Please note, these devices can continue to be safely used in line with the mitigations described below and within the Field Safety Notices. Providing patients with safe and high-quality therapy devices is our top priority. We encourage you to read the field safety notices on this page to learn more about the mitigating actions you can take to ensure safe continued use.

Accuracy of FiO2 Delivery

(2022-CC-SRC-049)

Initiated March 2023

This issue affects the Trilogy EV300 (PN GB2200X15B), Trilogy EVO O2 OBM (PN GB2100X11B), and Trilogy Evo Universal only.

Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient’s lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen.

The potential for this hazard is most likely to occur when the oxygen blending module (OBM) is used to manage patients requiring high volumes of oxygen such as scenarios requiring FiO2 setpoint greater than or equal to 70%.

This issue does not affect the Trilogy Evo device which is typically used in the home environment.

The Medical Device Correction provides immediate solutions to address safe continued use of the ventilators.

Providing patients with safe and high-quality therapy devices is our primary focus. We encourage you to read the Trilogy Evo FiO2 Medical Device Correction to learn more about the mitigating actions you can take to ensure safe continued use.

Medical Device Correction: Accuracy of FiO2 delivery

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Questions and answers

Environmental Contamination of Device Sensor

(2023-CC-SRC-003)

Initiated April 2023

This issue affects all Trilogy Evo Platform devices: Trilogy Evo (GB2110X15B), Trilogy EVO O2 OBM (GB2100X11B), Trilogy Evo Universal, Trilogy EV300 (GB2200X15B)

Philips Respironics has detected contamination in the air path of some devices that have been returned from the field. Philips Respironics has confirmed the material is environmental contamination, such as dust and dirt. Extended exposure to these environmental contaminants can lead to buildup of particulate on a flow sensor within the device. This may cause the device to inaccurately deliver pressure, volume, or flow.

Replacing the Trilogy Evo particulate filter:

Medical Device Correction: Environmental Contamination of Device Sensor

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Questions and answers

Continued Use of Trilogy Evo Platform of Ventilators

Please note, when the mitigating actions specified in the Trilogy Evo platform of ventilators Field Safety Notice are taken, the Trilogy Evo platform of ventilators continues to be an alternative for:

Philips Respironics Trilogy 100/200 devices impacted by an issue related to sound abatement foam
Philips Respironics V60 and V60 Plus devices impacted by an issue related to the power management PC board
New patients needing treatment

As a health technology company, it is critical that we have and abide by strong quality and regulatory processes. The release of the field safety notice further enforces Philips Respironics dedication to patient safety by informing customers about issues that could potentially affect patients, and providing solutions that address these concerns.

If you have any questions or need further support concerning this issue, please contact your local Philips representative.

We appreciate your patience and trust as we continue to act quickly to release this correction.

Questions and answers

Could under delivery of FiO2 occur in the home environment?

Could under delivery of FiO2 occur in the home environment?

This issue is only experienced when the Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300 high pressure oxygen blending module (OBM) is used to manage patients requiring high volumes of oxygen such as scenarios requiring FiO2 setpoint of greater than or equal to 70%. The Trilogy EV300 and Trilogy Evo Universal models are only approved for hospital use. Generally, the Trilogy Evo O2 high pressure oxygen blending module is not typically used in the home environment as low pressure oxygen sources, such as stationary oxygen concentrators, are a common option to bleed in O2 in the home.
What is Philips Respironics’ long-term corrective action for this issue?

What is Philips Respironics’ long-term corrective action for this issue?

Philips Respironics will release a software update to correct this issue. This software will be available free of charge to all Trilogy Evo, Trilogy EVO O2 OBM, Trilogy Evo Universal, and Trilogy EV300 users. Additional detail will be provided when the update is available.
How do I ensure my patients safety in the short term until Philips Respironics has a long-term solution?
How do I ensure my patients safety in the short term until Philips Respironics has a long-term solution?
The risks of FiO2 under delivery in Trilogy EV300 and Trilogy Evo O2 models can be mitigated in the short-term when the following steps are taken:

Continuously monitor oximetry (SpO2) of the patient and follow your institution’s protocol for monitoring of arterial blood gas measurements to ensure that the patient is receiving adequate oxygenation.

Use an external FiO2 monitor for any patient requiring FiO2 ≥70% to identify under delivery of oxygen. Switch to an alternative ventilator if an external FiO2 monitor is not available.

Maintain an immediately available back-up device that will allow rapid transition to a different oxygen delivery method or alternative ventilator if monitoring suggests FiO2 is not being sufficiently delivered.

To help prevent accumulation of contaminants on the machine flow sensor:

Use the particulate filter which prevents a significant majority of airborne aerosols and particulate from entering the device. This must be replaced between patients and monthly as indicated in the Instructions for Use. Using this filter was previously optional. This is now required.

Use the air inlet filter as indicated in the Instructions for Use.

Installation of the particulate filter will not require a change to therapy settings.

To help detect change in therapy:

Set appropriate alarms based on ventilation mode, such as Low VT (Tidal Volume), Low Min VE (Minute Ventilation), LIP (Low Inspiratory Pressure), and High Inspiratory Pressure.

Check Proximal Pressure and External Flow Sensor Failed alarms can also alert the user to this issue. These are non-settable alarms.

Observe instructions for any alarm, especially including vent service required or ventilation inoperative. If the situation cannot be resolved, use alternative ventilation equipment.

Ensure ventilator-dependent patients have access to alternative ventilation equipment, such as a back-up ventilator or manual resuscitator.

In addition to training device users within your network to use the air inlet and particulate filters on all patients, these mitigating actions will help to ensure safe continued use of the ventilator until the software update can be released.