Urgent Product Defect Correction

*ACCC UPDATE 28/07/2021*

Please read the latest information from the ACCC (Australian Competition and Consumer Commission - Read Here

Re: Urgent Product Defect Correction

As a valued CPAP Victoria customer we would like to inform you of this Urgent Product Defect Correction for some Philips CPAP and Bi-Level PAP devices. Please see the latest statement from Philips below outlining the process on how to register to rectify this defect correction.

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.

At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

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 the specific affected devices.

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.

Following consultation with the Therapeutic Goods Administration (TGA), the notification advises patients and customers to take the following actions:

For patients using BiLevel PAP and CPAP devices: 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.

  • For patients using life-sustaining mechanical ventilator devices: 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.
  • For patients using life-sustaining mechanical ventilator devices (cont.):
    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.

Patients and customers will be asked to register affected devices via the link provided on www.philips.com/SRC-update. If the website cannot be visited or accessed customers can call 1800 009 579.

Customers will be provided a unique password and login with their notification.  They will be asked to provide details on their Managed Units and User Notifications. Managed units will consist of all devices which have been with a customer including devices sold to patients and not sold to patients; this includes inventory and demonstration units. Should customers choose so, they can have Philips manage the notifications to their patients via the User Notification option.

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 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.

For more information on the status of the correction, visit www.philips.com/src-update or call 1800 009 579.

Kind regards,

Penny Stewart
General Manager
Sleep and Respiratory Care