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

Philips Respironics

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.

Out of an abundance of caution and based on the latest available information, Philips issued a field safety notice on June 14, 2021 in connection with potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

 

 In consultation with relevant regulatory agencies, Philips has refined the field safety notice for specific countries in Europe.

 

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. High heat and high humidity environments may also contribute to foam degradation in certain regions.

 

 

At the time of the June 2021 field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the  field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve.

The notification 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 do not use ozone-related cleaning products.

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.

 

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

 

The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.

 

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 philips.com/SRC-update.

What you need to do

 

Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. We have established a claims processing and support center to assist you.

Icon Business

Care providers, Distributors or Medical Institutions​

 

Click the link below to begin our registration process.

 

After registration, we will notify you with additonal information as it becomes available.

0800 249 4578 (UK) (0044) 20 8089 3822 (Outside of UK)

Icon Patient

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 claim if their unit is affected.

 

At this time, this process is only available for Patients, Users, or Caregivers in the USA, Canada, U.K., and European Union. More countries will be added shortly.

0800 249 4578 (UK) (0044) 20 8089 3822 (Outside of UK)

Icon Medical professional

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

ST, AVAPS

60 Series CPAP, ASV

SystemOne

ASV4

C Series AVAPS/ST

C Series 

ASV, S/T, AVAPS

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

60 Series CPAP, ASV

SystemOne

(Q series)

DreamStation CPAP

DreamStation

CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO

CPAP, APAP

Dorma 400, 500

Dorma 400, 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

Trilogy 200

Garbin Plus, Aeris, LifeVent

Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A 40/30

A-Series BiPAP Hybrid A30

(not marketed in US)

V30

A-Series BiPAP V30 Auto

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.

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200, & REMStar SE
  • 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?

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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