Urgent Product Defect Correction

Philips Australia

There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.

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

 

As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification 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. Additionally, the notification provides details of our repair and replacement program, to correct this issue as thoroughly as possible.

 

To implement the permanent corrective action, where possible, Philips will be contacting affected patients and customers with the relevant information on the next steps.

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 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.

We cannot stress enough that 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. 

Help

Questions? Call

1800 009 579 (toll-free)
Monday to Friday
9:00am – 6:00pm AEST

What you need to do

Icon Business

Therapy Providers, Distributors, or Medical Institutions​

 

  • For Therapy Providers, Distributors, Pharmacies or Medical Institutions: If you are in Australia, shortly you will receive a letter from Philips about this issue that contains log-in credentials for the registration website. If you do not receive this letter, please call the number below. After registration, we will notify you with additional information as it becomes available.

1800 009 579 (toll-free)

Monday to Friday
9:00am – 6:00pm AEST

Icon Patient

Patients, Users, or Caregivers​

 

  • 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.

1800 009 579 (toll-free)

Monday to Friday
9:00am – 6:00pm AEST

Icon Patient

Physicians and other medical care providers​

 

Click the link below for additional clinical details on the issue and other information to help you advise your patients who have been impacted.

What devices are affected?

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation     

ASV

DreamStation AVAPS

DreamStation

AVAPS

60 Series CPAP, ASV

SystemOne

ASV4 (50 and 60 Series)

C Series AVAPS/ST

C Series 

(50 and 60 Series AVAPS)

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

System one

SystemOne (Q Series)

(50 and 60 series)

DreamStation CPAP

DreamStation

CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO

CPAP, APAP

Dorma 500

Dorma 500

CPAP

REMStar SE Auto CPAP

REMStar SE Auto

CPAP

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100

Ventilator

Trilogy 200

Trilogy 200

Ventilator

Continuous Ventilator, Non-life Supporting

A 40/30

A-Series BiPAP A40

(not marketed in US)

A 40/30

A-Series BiPAP A30

(not marketed in US)

What products are not affected and why?

 

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

 

Products not affected by this recall notification include:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series
  • Omnilab (original based on Harmony 2)
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

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.

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