Field Safety Notice Philips Circuit Selection on Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 Platform User Interface (ICN 3012)

NHSSC: 48

• Philips Respironics has issued a Field Safety Notice due to a new issue related to the use of non-pneumatic nebulizers with Trilogy Evo Platform ventilators (Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 ventilators collectively) as well as updates regarding two prior communications regarding these same devices.
• New Information:
  • Use of non-pneumatic (e.g., Vibrating Mesh) Nebulizers Prohibited – Analysis of the impact of nebulizers on performance of Trilogy Evo Platform ventilators revealed that using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
  • Non-pneumatic nebulizers change the airflow characteristics by adding liquid droplets, causing the ventilator’s leak estimation calculation to be incorrect. This leads to under-delivery of therapy to the patient even though the graphic user interface does not display the change. This condition may occur with or without aerosol accumulation on the flow sensor.
  • Philips advise there have been three (3) complaints reported for this issue, including one (1) with minor injury and two (2) with no injury reported.

• Previously Communicated:
  • Nebulizer Use and Flow Sensor Impact – Depending on where a nebulizer is placed on the patent circuit, aerosol can enter the ventilator and accumulate on the internal flow sensor. Over time, this buildup may interfere with the sensor’s ability to accurately measure airflow, leading to incorrect flow calculations and potentially impacting the therapy delivered to the patient.
  • In these cases, the internal flow sensors should be replaced. Philips Respironics has conducted a review of complaints and identified 2 complaints received in October 2024 related to in-line nebulizer use.
  • There were no reports of injuries associated with these complaints. While Philips Respironics has not received any other specific complaints of device malfunctions resulting from in-line nebulizer use, they have performed a retrospective complaint review from product launch through 31 July 2024 and identified 928 complaints that, based on the symptoms reported in the complaint, may indicate the flow sensors were not performing as expected, with three (3) resulting in serious injuries.
  • Obstruction Alarm Timing – Analysis has shown that in some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards – two (2) breath cycles or five (5) seconds. In certain ventilation modes, with or without backup rates, the alarm could be delayed by up to four (4) breaths. No complaints or adverse events, including injuries and deaths, were reported that were attributed to this issue.

Next Steps:

• Update all Trilogy Evo Platform ventilators with software version 1.06.15.00. The software is available as free download through My Philips for Professionals (MyP4P) and InCenter websites. Refer to Appendix B Page 7 for instructions on how to acquire the software and update devices.
• See our Downloads ▼ section to view the User Manual Addendum. Ensure a copy of all product literature, including this User Manual Addendum, is included with every Trilogy Evo Platform ventilator in your possession.
• Stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all Trilogy Evo Platform ventilators.
• Communicate this urgent Field Safety Notice to anyone in your organization who interacts with a Trilogy Evo Platform ventilator, including clinicians, therapists, nurses, caregivers, and patients. Ensure they are aware of the changes regarding the use of nebulizers with these ventilators and that non-pneumatic nebulizers are not to be used.
• Complete the Field Safety Notice Response Form on Page 5 and email to: UKI_Quality_CR@philips.com.
• Please note this product is no longer available through NHS Supply Chain:

NHSSC: 48

Alert:

• Philips Respironics has issued a Field Safety Notice having become aware during internal testing of a potential issue that can occur when using preset circuit calibration settings with certain Fisher & Paykel (F&P) single limb circuits.
• Pressure delivery may incrementally exceed the specified limits (± 2 cmH2O + 4%) for pressure control accuracy when using the following circuit configurations with preset circuit settings configured on the device User Interface:
  • F&P Adult, RT202 single-limb inspiratory heated, 20 mm ID circuit, configured with the “Adult (20- 22mm)” circuit setting.
  • F&P Adult, 900MR810 reusable single-limb Evatherm circuit, configured with the “Adult/Paediatric (19mm)” circuit setting.
• All other critical parameters, including Tidal Volume measurements and alarms, continue to perform as expected and are not impacted by the circuit setting.
• Philips Respironics has determined this does not result in any new or increased risk to patients because any minor deviation in pressure delivery is compensated for when setting up the patient on the circuit and ensuring their comfort and compatibility.
• Philips Respironics advise it has not seen issues with the quality or performance of F&P circuits as they are manufactured or supplied.

Products Affected

• One of the products affected is available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice including to ensure variance in pressure does not occur, perform the Circuit Calibration when using F&P adult RT202 and 900MR810.
• Share the Field Safety Notice with all users of the affected products.
• Complete the Important Product Notice Response Form, page 5 of the Field Safety Notice, and return to: uki_quality_CR@philips.com

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.