Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Loss of Power Alarm (ICN 2493)

Alert:

• Philips Respironics has become aware of a potential safety issue with Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices where the ventilator can issue a Battery Depleted or Loss of Power alarm while sufficient power is still available.
• All Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices are susceptible to this problem.
• This can result in a sudden loss of ventilation while the device alarms.
• A Loss of Power event can cause irreversible harm to the most vulnerable patient populations, including death, if the associated alarm is not observed with the appropriate response. This is because the Loss of Power alarm will cause CPAP or PSV therapy to stop while the high priority alarm alerts the care provider to the issue.
• Philips Respironics, advise they have received twenty (20) reports of this malfunction and has observed no incidents of patient injury or harm.

Products Affected:

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

• Philips Respironics advise this malfunction will not happen in ventilation modes other than CPAP and PSV.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete the Customer Reply Form, page 4 of the Field Safety Notice, and return to safetynoticeuki@philips.com.
• Philips Respironics will follow up with the person who submitted this form with a full list of devices that were sold to the customer and for periodic progress on device software updates.

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.