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

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.