On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA), Philips Australia announced it is conducting an Urgent Product Defect Correction in Australia for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.
For more information on this Urgent Product Defect Correction, including a list of affected devices, please visit our main Urgent Product Defect Correction page.
The Urgent Product Defect Correction informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
To implement the permanent corrective action, where possible, Philips will be contacting affected patients and customers with the relevant information on the next steps. With this, your patients are likely to contact you for guidance and we are committed to providing you with information and tools to have an informed discussion with them and make your clinical recommendation. Please see the FAQs below and Clinical Information PDF here.
For the past 40 years we have centered our business around our commitment to patient care, with solutions that are aimed at improving the lives of people with respiratory and sleep challenges. We recognise the importance of providing safe and effective therapy.
We are committed to holding ourselves to the highest standards of product quality and safety in an effort to do what is right for you, and the patients who trust you with their care.
We are committed to resolving this issue and providing transparent, ongoing communication as we navigate the next steps.
We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently.
We cannot stress enough that, globally, 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 devices. 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.
For more information on the status of the product defect correction, visit www.philips.com/src-update or call 1800 009 579.
Our goods and services come with guarantees that cannot be excluded under the Australian Consumer Law. Consumer rights under the Australian Consumer Law are in addition to any remedy the local Philips entity may provide.
We sincerely apologise for this disruption. We are fully committed to supporting you and your patients throughout this process.