Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand)

Update related to Trilogy Evo platform of ventilators

Some Trilogy 100 users impacted by Philips Product Correction* 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 each applicable Urgent Product Defect Correction* notification are taken:

• Trilogy Evo continues to be an alternative for Trilogy 100 devices impacted by the June 2021 product correction* of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam

For more information on the March and April 2023 Urgent Product Defect Correction notifications related to the Trilogy Evo platform of ventilators, please click here. 

* Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand

Update related to Trilogy 100 repairs

Following the preparations and relevant clearances, the repair of Trilogy 100 ventilators (approximately 0.5% 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 ventilators following a limited number of complaints. 

Post market surveillance data indicate that silicone sound abatement foam installed in reworked Trilogy 100 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 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 devices.
 

Information for patients

Patient safety is our top priority, and we are steadfast in our commitment to quickly investigate, identify and address any potential corrections. To understand the actions you need to take, please read the below. We will provide you with additional information as it is available. 

Issue 1 - If a ventilator alarm such as 'Low Inspiratory Pressure' or 'Circuit Disconnect' sounds, and doesn’t resolve:

1. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilator’s operation. Always ensure you are being taken care of, i.e. That you are properly ventilated prior to referring to the instructions.
   
   IF THERE IS AN EMERGENCY, YOU MUST CALL 000
   
   
2. See ‘Ventilator Alarms’ on pages 2 – 4 of your Trilogy 100 Instructions for Use. Follow those instructions.
   
   
3. If you have a secondary (back up) device, switch over to that device.
   
   
4. Contact your clinical care team to determine if a loan device is required.
   
   

Philips Australia will work with your clinical care team to arrange a loan device, where required.

Issue 2 - Debris in Airway

Philips Australia has contacted state health providers regarding provision of an in-line bacterial filter. If prescribed, Philips is organising delivery of new inline bacterial filters. It is important to note that this is not ‘a fix’ to the problem, but this may help reduce exposure to any particulate matter until a permanent fix becomes available.

• You should closely monitor for possible accumulation of foam debris on the filter or resistance- related problems in the breathing circuit after filter placement. 
  
• Do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss any concerns.
   

Philips Australia is working closely with the Therapeutic Goods Administration (TGA) to ensure patients are kept informed of this situation. We will write to you, if necessary, with further appropriate actions.
 

Information for health professionals

Issue 1 - If a ventilator alarm such as 'Low Inspiratory Pressure' or 'Circuit Disconnect' sounds, and doesn’t resolve:

In the event of a High Priority alarm, clinical care teams may be contacted by the patient. Clinical care teams will determine if a loan device is required from Philips Australia. We have set up a dedicated channel to support the clinical care team with loan devices.  

If a loan device from Philips Australia is required please ensure the following details are provided in your call or email:

• Serial number of affected reworked Trilogy 100 device
  
• If the loan device needs to be sent directly to the patient:
  • Complete and current prescription for required device from the prescriber 
  • Patient name/care giver name and delivery details including phone number
    
• If the device is to be dispatched to a hospital:
  • Contact details of person receiving the device (this will be set unscripted with default settings)

• Filters may affect ventilator performance because they may increase resistance of air flow through the device.
• Patients should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.  
   

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 devices differs from the remediation process for all other affected devices. Given this, and the nature of the issue, these issues are isolated to the remediated Trilogy 100 devices only. 
 

Why is the remediation process different for Trilogy 100 compared to affected CPAP and BiPAP devices?
The design of the Trilogy 100 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?

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 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?
Philips Australia will contact affected customers. The devices are identified by Serial Number. The Serial Number is located on the bottom of the Trilogy Ventilator.

When will you restart the process of remediating the Trilogy 100 devices?

We understand the burden these issues put on your business and resources. Philips Respironics is developing a permanent corrective action in coordination with competent authorities.