Urgent Product Defect Correction

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.

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.

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.

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.

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.

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.

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.

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.

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.