News and Updates > Ventilation news and updates
Ventilation news and updates
April 14, 2023
Update related to Trilogy Evo platform of ventilators
Some Trilogy 100/200 and V60/V60 Plus users impacted by Philips Respironics recalls may be using the Trilogy Evo platform of ventilators as an alternative. Please be aware of recent important product updates related to the Trilogy Evo platform of devices. Please note, when the mitigating actions specified in the Field Safety Notices are taken:
For more information on the February and March 2023 field safety notices related to the Trilogy Evo platform of ventilators, please click here.
Updated: March 20, 2023
Published: December 12, 2022
Update related to Trilogy 100/200 repairs
Following the preparations and relevant clearances, the repair of Trilogy 100/200 ventilators (approximately 3% of the registered affected devices globally) has started in recent months. To date, we have remediated a limited number of registered Trilogy devices. Philips Respironics has detected two issues with these corrected Trilogy 100/200 ventilators following a limited number of complaints.
Post market surveillance data indicate that silicone sound abatement foam installed in reworked Trilogy 100/200 devices may potentially separate from the plastic backing to which it is adhered. Separation of the foam could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. This issue only affects the Trilogy 100/200 ventilators that have already been repaired. Additionally, Philips Respironics has observed residual PE-PUR sound abatement foam in some devices that were returned to the field. These cases were limited but further exposure to PE-PUR sound abatement foam should be avoided.
These problems do not affect any of the DreamStation CPAP or BiPAP sleep apnea devices that have been remediated and distributed to patients or homecare providers.
While Philips Respironics works to resolve these issues, the company has temporarily suspended the repair of Trilogy 100/200 devices.
Patient safety is our top priority, and we are steadfast in our commitment to quickly investigate, identify and address any potential corrections. For more information regarding these identified issues, and to understand the actions you need to take, please read the complete Field Safety Notice below. We will provide you with additional information as it is available.
Questions and Answers
Will these issues affect other remediated Philips Respironics CPAP, BiPAP, and ventilator devices?
These issues do not affect any of the DreamStation CPAP or BiPAP sleep apnea devices that have been remediated. The remediation process for Trilogy 100/200 devices differs from the remediation process for all other affected devices. Given this, and the nature of the issue, we are confident that these issues are isolated to the remediated Trilogy 100/200 devices only.
Why is the remediation process different for Trilogy 100/200 compared to affected CPAP and BiPAP devices?
The design of the Trilogy 100/200 devices differs from the design of other CPAP and BiPAP devices affected by the recall. An adhesive is required to hold the sound abatement foam in place on the air inlet assembly. This adhesive is not necessary in other CPAP and BiPAP devices, which is why they are not affected by the foam delamination issue.
How did this happen? Why should I trust your remediation process of Trilogy 100/200?
Our promise to our patients and customers is that we take action whenever a solution begins to fall short of the highest industry standards. We recognize the challenges this recall has created for you and the affect it has on your business and resources. In this case, our quality and complaint systems operated as intended and we were able to halt shipments as soon as we were aware of a potential issue with remediated Trilogy 100/200 devices. Philips Respironics remains committed to providing safe devices to all registered patients and correcting this issue will allow us to continue to remediate devices effectively.
How can customers identify affected units?
A list of equipment affected by this issue is included with this letter. The devices are identified by Serial Number. The Serial Number is located on the bottom of the Trilogy Ventilator.
