Philips Australia - Urgent Product Defect Correction

Dear Valued Customer,

On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA), Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. See list of affected devices at the end of this letter.

What is the defect?

The defect relates to foam insulation used inside the affected devices, made out of polyester-based polyurethane (PE-UR), which can degrade and cause particles and gas to be given off, and blown into a patient’s lungs.

What are the potential symptoms?

Philips has stated that potential symptoms include headache, irritation and/or inflammation of the lungs, broader respiratory issues, and “possible toxic or carcinogenic effects”. To read Philips’ statement, click here. According to Philips “To date, there is no definitive evidence of long-term harm to patients caused by either issue. There have been no reports of death due to exposure to the particulate matter or gas.”

What should patients do now?

Philips has advised patients to not cease use of these devices without speaking to their physician or care provider. Together with the patient’s physician or care provider, determine if the benefits of continuing therapy with the device outweighs the risks identified and discuss alternative long term therapy options.

Patients will need to register their device on the website: <a href=""http://www.philips.com/src-update"">www.philips.com/src-update</a>. This will allow Philips to contact them to organise corrective actions or replacements.

Philips has established a hotline to assist affected patients with any questions they may have in relation to this. Call 1800 009 579 (toll-free) Monday to Friday 9am – 6pm AEST.

What is the Australasian Sleep Association’s position on this?

According to Associate Professor Alan Young, President of the Australasian Sleep Association, “If your machine is one of the affected models, you should speak with your sleep doctor or GP about whether or not you should keep using your machine…

Patients really rely on these machines to keep them feeling well and productive and in some cases to keep them alive. It’s very important that you discuss your individual situation with your sleep doctor or GP and continue to use your machine until that time…

This problem is a very rare issue, and there have been no serious health problems that have been reported. But it is important that patients are aware of this issue, register their machine with Philips, and discuss their individual situation with their sleep doctor or GP.”

To read the ASA’s full statement, click <a href=""https://www.sleep.org.au/Public/News/Articles/July/media-release-philips.aspx"">here</a>.

Sove CPAP Clinic’s Commitment

The health and safety of all our customers is our number one priority.

We are working closely with Philips to keep our patients, referring GPs and physicians updated with the latest developments, and to assist our patients through the Philips’ process.

If you have any questions or concerns regarding your affected Philips device, you can speak with a Sove CPAP Clinic Consultant on 1300 76 29 39 or email us at <a href=""mailto:info@thecpapclinic.com.au"">info@thecpapclinic.com.au</a>.

<table border=”“1”” cellpadding=”“20””>

Immediate Action to be taken by You, the User

Following consultation with the TGA, the advice to patients and customers is to take the following actions:

• Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long term therapy options.

• Do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.

• If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter.

We cannot stress enough that Philips is treating this matter with the highest level of seriousness and is dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. However, due to the volume of devices, we regret it may take some time to repair or replace your device. Presently, Philips is unable to confirm the repair or replacement timeframes.

We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.

Our goods and services come with guarantees that cannot be excluded under the Australian Consumer Law. Your rights under the Australian Consumer Law are in addition to any remedy the local Philips entity may provide you.

</table>

What you need to do

• Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a registration if their unit is affected. Register their device via <a href=""http://www.philips.com/src-update"">www.philips.com/src-update</a>.
• Philips has established a hotline to answer any questions in relation to this Urgent Product Defect Correction. Call 1800 009 579 (toll-free) Monday to Friday 9am – 6pm AEST
• Contact your Physician or care giver for specific advice based on your situation.

Affected Devices

CPAP and BiLevel PAP Devices

Mechanical Ventilators

Links:

• <a href=""https://www.sleep.org.au/Public/News/Articles/July/media-release-philips.aspx"">Statement from Australasian Sleep Association</a>
• <a href=""https://www.philips.com.au/healthcare/e/sleep/communications/src-update"">Philips Statement</a>