Urgent Product Defect Correction

Philips Australia

Information for Physicians and other medical care providers​

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. 

Following consultation with the TGA, the advice to patients and customers is 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.
  • 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.

Questions and answers

Are affected devices safe for use? Should affected devices be removed from service?

Following consultation with the Therapeutic Goods Administration (TGA), the Urgent Product Defect Correction will advise 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.
  • 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.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?

The Urgent Product Defect Correction informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.

 

Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.

 

In the event of exposure to degraded foam:

 

  • The potential risks of degraded foam exposure include:
    • Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.
  • To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

 

In the event of exposure to chemical emissions:

 

  • The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
  • To date, Philips has not received reports of patient impact or serious harm as a result of this issue.
When will the correction for this issue begin? How long will it take to address all affected devices?

Philips is notifying regulatory agencies in the regions and countries where affected products are available.

 

We are providing agencies with required information related to the projected correction.

 

The company will replace the current sound abatement foam with a new material that is not affected by this issue.

 

Presently, Philips is unable to confirm the repair or replacement timeframes. We will do so when this information is available.

 

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 Philips may provide.

Are affected devices continuing to be manufactured and/or shipped?
At this time, affected devices are on manufacturing and ship hold.
How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to warranty replacement, repair, service or other mitigations?

We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.

 

Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products. 

 

Presently, Philips is unable to confirm the repair or replacement timeframes. We will do so when this information is available.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

 

The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.

 

Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

 

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 Philips may provide.

Are there any steps that customers, patients, users and/or clinicians should take regarding this issue?

Customers, patients, users and clinicians are instructed to follow the guidance contained in the notification.

 

Following consultation with the Therapeutic Goods Administration (TGA), the notification will advise 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 in this letter 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.
  • 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.

 

  • For Patients, Users, or Caregivers 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.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

 

Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

What is the cause of this issue? Was it a design, manufacture, supplier or other problem?
Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.
How did this happen, and what is Philips doing to ensure it will not happen again?

Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue.

 

The products were designed according to, and in compliance with, appropriate standards upon release.  As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes.  Philips Quality Management System has been updated to reflect these new requirements.

 

However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

 

Philips has been in full compliance with relevant standards upon product commercialization.

What is meant by "high heat and humidity" being one of the causes of this issue?

Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature.

 

The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. 

 

This factor does not refer to heat and humidity generated by the device for patient use.

Can Philips replace products under warranty or repair devices under warranty?

Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units.

 

Presently, Philips is unable to confirm the repair or replacement timeframes. We will do so when this information is available.

 

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 Philips may provide.

In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Will existing patient devices that fail be replaced?

At this time, Philips is unable to set up new patients on affected devices.

 

Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care.

 

Philips CPAPs cannot be replaced during ship hold.

 

Presently, Philips is unable to confirm the repair or replacement timeframes. We will do so when this information is available.

 

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 Philips may provide.

Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected?

Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers.

 

No further products are affected by this issue.

Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox.