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: www.philips.com/src-update. 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 here.
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 email@example.com.
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:For patients using Bi-Level PAP and CPAP devices:
For patients using life-sustaining mechanical ventilator devices:
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 www.philips.com/src-update.
- 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.
CPAP and BiLevel PAP Devices