Trilogy Evo Platform of Ventilators Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand)

Philips Respironics has identified two problems that could pose a risk for patients if not mitigated. Please note, these devices can continue to be used in line with the mitigations described in the Urgent Product Defect Correction notifications in Australia and the Recall for Product Correction notifications in New Zealand. If you require a copy of these notifications, please contact Philips.

Accuracy of FiO2 Delivery

(TGA Reference: RC-2023-RN-00209-1, Medsafe Reference: 30783)

Initiated March 2023

Philips following consultation with the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand, is conducting an Urgent Product Defect Correction of Philips Respironics Trilogy Evo O2 and Trilogy EV300.

A problem has been identified within the Philips Respironics Trilogy Evo O2 and Trilogy EV300 ventilators that could pose a risk for patients if not mitigated.

Impacted Devices
Model #	Description
IN2200X15B	Trilogy EV300
IN2100X15B	Trilogy Evo O2

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 Trilogy Evo 02 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 greater than or equal to 70%.

Trilogy Evo, which is not configured with a high-pressure oxygen blending module (OBM), is not impacted by FiO2 under delivery.

The Urgent Product Defect Correction provides important information for the continued use of your equipment. If you require a copy of this correction notification, please contact 1800 830 517 in Australia (toll-free) or +61 2 7255 2450 in New Zealand.

Environmental Contamination of Device Sensor

(TGA Reference: RC-2023-RN-00318-1, Medsafe Reference: 31061)

Initiated April 2023

Philips following consultation with the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand, is conducting an Urgent Product Defect Correction of Philips Respironics Trilogy Evo, Trilogy Evo 02 and Trilogy EV300.

A problem has been identified with the Philips Respironics Trilogy Evo, Trilogy Evo 02 and Trilogy EV300 ventilators that could pose a risk for patients if not mitigated.

Impacted Devices
Model #	Description
IN2100X15B	Trilogy Evo O2
IN2200X15B	Trilogy EV300
AU2110X15B	Trilogy Evo, Australia
IN2110X15B	Trilogy Evo, International

Philips Respironics has detected environmental debris (e.g., external dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental debris can lead to buildup of particulate on the internal flow sensor within the device. This may cause the device to inaccurately deliver pressure, volume, or flow.

A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

Using a particulate filter prevents a significant majority of airborne aerosols and particulate from entering the device. Using this filter was previously optional. This is now required.

The Urgent Product Defect Correction provides important information for the continued use of your equipment. If you require a copy of this correction notification, please contact 1800 830 517 in Australia (toll-free) or +61 2 7255 2450 in New Zealand.

Continued Use of Trilogy Evo Platform of Ventilators

Please note, when the mitigating actions specified in each applicable Trilogy Evo platform of ventilators Urgent Product Defect Correction notification are taken, the Trilogy Evo platform of ventilators continues to be a recommended alternative for:

Philips Respironics Trilogy 100 devices impacted by an issue related to sound abatement foam.

As a health technology company, it is critical that we have and abide by strong quality and regulatory processes. The release of the Urgent Product Defect Correction notifications further enforces Philips’ dedication to patient safety by informing customers about issues that could potentially affect patients and working to address these issues.

If you need any further information or support concerning this issue, please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 7255 2450 in New Zealand.

Questions and answers

Will loan devices still be available?

Will loan devices still be available?

Philips Respironics will continue to provide Trilogy Evo platform loan devices. Please note, these devices can continue to be used in line with the mitigations described in each applicable Urgent Product Defect Correction as well as in accordance with the Instructions for Use.
Could under delivery of FiO2 occur in the home environment?

Could under delivery of FiO2 occur in the home environment?

The potential for this hazard is most likely to occur when the Trilogy Evo 02 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 greater than or equal to 70%. The Trilogy EV300 model is only approved for hospital use. Generally, the Trilogy Evo O2 high pressure oxygen blending module is not used in the home environment as low pressure oxygen sources, such as stationary oxygen concentrators, are a more common option to entrain oxygen in a home environment.

Trilogy Evo, which is not configured with a high-pressure oxygen blending module (OBM), is not impacted by FiO2 under delivery.
What are you doing to fix the under delivery of FiO2 issue?

What are you doing to fix the under delivery of FiO2 issue?

Philips Respironics will release a software update that will address the issue. This software will be available free of charge to all affected users. Additional details will be provided when the update is available. Please also see the question “What actions should patients and customers take?”
Will the software update for the under delivery of FiO2 issue be mandatory?

Will the software update for the under delivery of FiO2 issue be mandatory?

Philips Respironics will release a mandatory software update that will address the issue when the software is available. This software will be available free of charge to all affected users. Additional details will be provided when the update is available.
What actions should patients and customers take?
What actions should patients and customers take?
Accuracy of FiO2 Delivery (Please see above for impacted devices)
Until the software update is provided by Philips Respironics, the following precautions must be observed:

Distribute this notice to all employees in your organisation that need to be aware.

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.

Environmental Contamination of Device Sensor (Please see above for impacted devices)
To help prevent accumulation of debris on the machine flow sensor:

Use the Philips approved particulate filter which prevents a significant majority of airborne aerosols and particulate from entering the device. This filter 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 Tidal Volume, Low Minute Ventilation, 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.

The device will issue a low priority Inlet Filter(s) Blocked alarm if therapy is reduced due to filter occlusion. The device will continue to function if this occurs, but the user must be aware to rinse the air-inlet filter and replace the particulate filter if this occurs. Observe instructions for any alarm, especially Ventilator 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.

Distribute this notice to all employees in your organisation that need to be aware. In addition, train device users within your network to use the air inlet and particulate filters on all patients.