Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators - Update on Trilogy 100 Ventilators

Philips Respironics (the manufacturer) has detected two problems with corrected Trilogy 100 ventilators.

These problems only affect the Trilogy 100 ventilators that have already been corrected as part of the ongoing actions related to the PE-PUR sound abatement foam in these devices.

These problems do not affect any of the CPAP or BiPAP machines that have been replaced with new machines.

What are the problems with the corrected Trilogy 100 ventilators?

Problem 1 - Foam blocking the airway

The new silicone sound abatement foam, installed into the ventilators, to replace the PE-PUR foam, may dislodge from its position and block the air pathway. This can stop the device from working and will trigger an alarm, either ’Low Inspiratory Pressure’ or ’Circuit Disconnect’.

Problem 2 - Debris in airway

Trace amounts of particulate matter has been found in the air pathway of some corrected ventilators. Some of the particles are PE-PUR foam debris but there is other material that hasn’t yet been identified.

What if I have a CPAP or BiPAP?

No action is required if your CPAP or BiPAP machine was replaced by Philips.
Philips has confirmed the new machines are not affected by the above problems. The silicone foam is held in place by compression and cannot move and no PE-PUR foam is in these new machines.

These problems are still being investigated. Until the cause has been confirmed, Philips cannot fix these devices. In the interim, Philips is offering users the following support.

What do I need to do?

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

• Switch over to your other device.
• Call the Philips Hotline on 1800 830 517. A Philips Clinical Expert will discuss possible options, which may include using a Philips Trilogy Evo as an alternative device.

Problem 2 - Debris in Airway

Philips is contacting your state health providers and prescribers to arrange delivery of a new inline bacterial filter. It is important to note that this is not a fix to the problem, however, will help minimise exposure to any particulate matter until a permanent fix becomes available.

Do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss any concerns.

What is Philips doing?

Philips Respironics is investigating these problems and will keep you informed of this situation. Once the cause of these problems is determined, further appropriate corrective action will be initiated.  

Further information

Contact the Philips Sleep & Respiratory Care support hotline on 1800 830 517 for further information and support.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.