Medical Device Field Safety Notice (Outside of U.S.)

Philips Respironics

Information for Physicians and other medical care providers​

Philips Respironics announced a voluntary recall notification (U.S. only) / field safety notice (Outside of U.S.) 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 Field Safety Notice, including a list of affected devices, please visit our main Field Safety Notice page.

 

Philips is working tirelessly to remedy this issue by replacing the affected devices. A recall notification (U.S. only) / field safety notice (Outside of U.S.) with immediate actions to be taken has been sent to distributors and institutions that are a direct customer of Philips for their own use as well as for engagement with patients. 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 recognize 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.

For other inquiries or to speak with a support specialist, you can also call (00353)1800851241 (Ireland) (0044) 20 8089 3822 (Outside of Ireland).

 

We sincerely apologize for this disruption. We are fully committed to supporting you and your patients throughout this process. 

For patients and users, The Field Safety Notice also advises: 

 

For patients using BiLevel PAP and CPAP devices: 

 

  • Please contact your physician or care provider before making any changes to your prescribed therapy.
  • While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment.
  • Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.  

 

For patients using life-sustaining mechanical ventilator devices : DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.

 

Philips is recommending that customers and patients do not use ozone-related cleaning products .

Questions and answers

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

The field safety notice advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Please contact your physician or care provider before making any changes to your prescribed therapy. While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment. Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.

 

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 field safety notice 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.
  • At the time of the issuance of the June 14, 2021 / field safety notice, Philips Respironics 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 had 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.
  • At the time of the issuance of the June 14, 2021 / field safety notice, Philips had 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?

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

 

At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible.

 

Philips will provide further clarity on projected dates for implementation of the correction to begin when this information is available.

 

The process for preparing the corrections indicated in the field safety notice has begun.

 

This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.

 

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

 

Our global repair and replacement program for affected devices is being implemented in accordance with appropriate regulatory requirements in each market, which may, in some markets, include review and/or authorization by the relevant regulatory agencies.

 

We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction.

Are affected devices continuing to be manufactured and/or shipped?
At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.
Is this a recall? Have regulatory authorities classified the severity of this action?

The issuance of the notification is a field safety notice in the U.K. and Ireland, according to regulatory agency criteria.

 

This field safety notice has not yet been classified by U.K. and Ireland regulatory agencies.

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.

 

As a result of extensive ongoing analysis the company issued a field safety notice for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

 

The notification 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.

 

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 currently 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.

 

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, and has already begun this process. 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.

 

For more information on the field safety notice, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

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 field safety notice (International Markets).

 

The field safety notice advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Please contact your physician or care provider before making any changes to your prescribed therapy. While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment. Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
  • Register affected devices on the field safety notice website, www.philips.com/SRC-update.
    • The website provides current information on the status of the field safety notice and how to receive permanent corrective action to address the two issues.
    • The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process.

 

The company has developed a comprehensive plan for this correction, and has already begun this process.

 

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.

 

For more information on the field safety notice, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

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.

Do affected units exhibit features that customers / users should watch out for? Particles or other visible issues?
Users should consult with their physicians as directed in the field safety notice.
Can Philips replace products under warranty or repair devices under warranty?
Philips will provide further information regarding warranty replacement procedures during this issue when it is available.
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.

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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