Philips Respiratory Devices – information for patients

TGA Product Defect Correction on some Philips respiratory devices  

Information current as at  3 March 2023

On 2 July 2021 the Therapeutic Goods Administration (TGA) issued a Product Defect Correction on a range of Philips respiratory devices. The notice is due to potential health risks related to the sound abatement foam component in some sleep and respiratory care devices.

You can read more about this on the TGA website as well as the Philips website.

The information contained on this page is intended only for people who have been provided a Philips respiratory device through the EnableNSW Home Respiratory Program (HRP).

If this situation impacts you, we encourage you to review this page often. As this situations changes and new information is available, we will update this page regularly.

Is my respiratory device affected by the TGA Product Defect Correction?

The Philips website has a list of the affected Philips respiratory devices. If the device you are using is listed on the website, please contact your respiratory clinician to decide on next steps.

Is it safe if I continue using my Philips respiratory device?

The advice from Philips, the TGA and the Clinical Excellence Commission (CEC) is you should not stop using your device unless your respiratory clinician or care provider has told you to do so.

Your clinician will work with you to decide if the benefit of continuing use of your current device outweighs the risks identified and discuss alternative long term options where available.

If you are concerned, you should make an appointment with your respiratory clinician as soon as you can.

I can see black particles in my Philips respiratory device, should I stop using it?

Please contact your respiratory clinician as soon as you can.

Any decision about stopping the use of your device must be made in consultation with your respiratory clinician. They are being sent up to date information from Philips and other agencies and they will work with you to make the right decision.

You should also contact our team to report this issue about your device. You can do this on 1800 362 253 (option 3) or send an email to enable@health.nsw.gov.au.

I have been experiencing symptoms such as sore throat, coughing or headaches – who should I talk to?

You should speak to your respiratory clinician or regular health professional as soon as you can. They know your medical history and can give you the best advice about your health situation.

They may also be able to tell you if your symptoms are related to this issue or something else.

Who will correct or replace my device?

As the manufacturer, Philips is arranging to correct (the defect) or replace your device. It is important you respond to any communication you receive from Philips regarding your replacement.

Do I need to register my device on the Philips website for the correction or replacement to take place?

If you are using a Philips respiratory device that has been provided to you through the EnableNSW Home respiratory program (HRP), our team has already registered your device with Philips and provided your contact details.

If your contact details have changed since you last contacted us, please let us know by sending an email to enable@health.nsw.gov.au.

Will I be asked to pay any money for the correction or replacement of my Philips respiratory device?

No. Philips will carry out the correction or replacement of your device and there will be no cost to you.

Will my device be corrected or replaced?

Some Philips respiratory devices will only need to have an internal part of the device replaced – this is called a correction. The Philips team will make contact with you and let you know how this will happen. Please ensure you respond to any communication you receive from Philips to prevent any delays.

For some devices, a replacement device may be the best option.

If you have any questions about this, please write them down and talk to the Philips representative when they contact you.

I am using a Philips respiratory device that needs an urgent repair – who can I talk to about this?

The current Philips situation means that usual repairs to Philips respiratory devices cannot happen at this time.

If your machine is not working as expected, please call our repairs team on 1800 362 253 (option 2) and they will let you know what options are available to you.

Can I move to a new device from another supplier?

It is important you discuss your individual circumstances with your respiratory physician before you make any decisions about your device. They know your health situation and can advise the right next steps for you.

If your respiratory clinician makes a clinical recommendation to move you to a new device, we need the right information from your clinician, including device settings to move you. For your safety, we need to ensure we provide you with the right device to suit your clinical need.

Once we have received advice from your respiratory clinician we will do our best to fulfil your request where available.

There is currently a high demand for alternative supplier devices. We are prioritising devices that need to be repaired and any person who is commencing their therapy. We appreciate your patience and understanding.

I have read or heard news in the media that is causing me concern. Who should I speak to?

We urge you to speak to your respiratory clinician as soon as you can. They are being sent up to date information from Philips, the TGA and the Clinical Excellence Commission as soon as it’s available. This means your respiratory clinician is best placed to answer any questions or concerns you have about your individual situation.

I can’t get through to the Philips customer contact centre – what are my options?

As expected, the Philips team are receiving a higher volume of calls at this time on their 1800 009 579 number. Philips are aware some people are having difficulty making contact with their team and have advised us that additional resources are being put into place to manage the call volumes.  Alternatively you may wish to send the Philips team an email at sleepservicepatients@philips.com.

We understand the frustration this may be causing, however we do encourage you to keep trying to make contact with the Philips team.

Information on their website is being updated regularly including a Questions and Answers page that may also be helpful to you.

I no longer use my Philips device OR I have a device that was being used by a person who has now passed away – what do I do with the device?

Please contact our team on 1800 362 253 (option 3) or send an email to enable@health.nsw.gov.au and we will provide your details to Philips who will then arrange to have the device collected. At this stage we do not know when this might happen.

If you are sending an email, please include the following information

• The persons full name
• Contact person (if different from the person who was provided the device)
• Contact number or email
• Pick up address

Please note we will only collect devices that have been provided through the EnableNSW Home respiratory Program (HRP). If you have purchased your device through a retailer (such as a chemist), please contact Philips directly on 1800 009 579 or send an email to sleepservicepatients@philips.com.

Philips Rectification Plan update

When will Philips start replacing or repairing devices?

Philips has  commenced shipping devices to all NSW Health patients.

Devices will be replaced with a new or substitute device, while others will be eligible for a repair.

How will Philips contact me?

Philips will contact patients by phone to confirm device usage (active/inactive), contact, and shipping details.

Who will collect my old device?

Philips will be responsible for the collection of the old device through Australia Post at no cost to the patient. A copy of the return instructions have been sent with your new Philips replacement device or will be if you have not received yours. Please contact Philips on 1800 830 517 for help with the returns process.

Who will help me set up my new device?

The replacement device will come with instructions on how to contact the Philips Customer Correction Team for support over the phone, or to arrange a time to book a telehealth appointment or a face-to-face appointment (if possible). Patients may also request a follow-up call from Philips.

What are the warranty periods for replacement or repaired devices?

Replacement devices (New or Substitute devices) will come with a 2-year warranty or the unexpired warranty period of the affected device, whichever is longer.

Repaired devices will have a 1-year warranty on the parts repaired or the unexpired warranty period of the affected device, whichever is longer.

Why have I received an additional power-cord for my device?

An additional power-cord has been sent as a replacement to your existing power-cord. There are no safety concerns or issues with the existing power-cord, however the newest power-cord is more robust and will ensure your respiratory device performs at its best.

Please detach and safely dispose of your old power-cord. Attach the replacement power-cord to your device.

For more information, please refer to your device user manual. If you require further assistance or have any additional questions, please contact Philips on 1800 830 517

What are the issues with the corrected Trilogy 100 ventilators?

There have been some issues identified with the corrected Trilogy 100 ventilators. Please review the issues below and take appropriate action if any issues/faults arise.