Panasonic Respironics Continuous Airway Pressure Device

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

Philips Respironics Sleep and Respiratory Care devices

FSN 2021-05-A & FSN 2021-06-A

• 700 000
  

  Number of repair kits and replacement devices produced for Western Europe¹
  

  45 448
  

  Number of devices delivered to the United Kingdom²
  

  1. Western Europe inludes: Denmark, Austria, Germany, Switzerland, Greece, United Kingdom, Ireland, Finland, Belgium, France, Israel, Italy, Netherlands, Norway, Portugal, Sweden, Spain

  2. Number of remediated devices shipped to customers in the United Kingdom as of September 30th  2022. This number will be updated monthly.

  By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein.

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In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.).

We know the profound impact this field safety notice has had on our patients, business customers, and clinicians – which is why we've created tools and resources that can offer support throughout this process. You can find these materials on NHS Patient, Patients, Business customer, and Clinician pages.

We aim to complete the repair and replacement program for the majority of registered patients by December 2022. While we are making progress, we realize that for patients waiting for a repaired or replaced device, progress can't come fast enough.

We are committed to sharing regular updates on our efforts via this website and emails to our customers and registered patients, including timing specific to when you will receive your replacement device(s).

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Not yet registered?

Support line 0800 249 4578 (UK) or (0044) 20 8089 3822 (outside of UK)

New and reassuring results

July 25, 2022  - Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk
Philips Respironics engaged external scientific experts to perform an independent systematic literature review of epidemiological studies to evaluate whether use of Continuous or Bilevel Positive Airway Pressure (PAP) devices increases the risk of cancer in obstructive sleep apnea (OSA) patients.

Based on 13 epidemiological studies identified from the systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with OSA. Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

June 28, 2022 - Philips provides update on Philips Respironics' PE-PUR sound abatement foam test and research program.

Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice

Technical Project Manager Jan Bennik speaks about the test and research program

May 24, 2022 - An analysis was published online in the European Respiratory Journal that concluded thatsustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers' devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years.
The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.

Dec 15, 2021 - A completely independent Canadian study was published in the American Journal of Respiratory and Critical Care Medicine.
This study did not show a higher risk in patients with CPAP compared to patients using a device from another manufacturer.

Questions and answers

• General (6)

  General (6)

  What is the issue?

  • The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. This is a potential risk to health. After careful analysis, we issued a Field Safety Notice (Outside of U.S.).
  • We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. Please be assured that we are doing all we can to resolve the issue as quickly as possible. We thank you for your patience as we work to restore your trust.

  What is the advice for patients and customers?

  • If you have not done so already, please click here to begin the device registration process.
  • Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a healthcare provider to decide on a suitable treatment for medical conditions, which may include:
  • Stopping use of an affected device.
  • Using another similar device that is not part of the field safety notice.
    
  • Continuing to use an affected device, if a patient's healthcare provider determines that the benefits outweigh the risks identified in the field safety notice.
    
  • Using alternative treatments for sleep apnea.

    For patients using life-sustaining mechanical ventilator devices, they  should not stop or change ventilator use until they have talked to their healthcare providers regarding factors including:

  • Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the field safety notice.
    
  • Consultation with healthcare providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips field safety notice, which also notes limitations of this option and areas of caution.
    
  • We strongly recommend that customers and patients do not use ozone-related cleaning products. Additionally, we remind both customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
  • Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible.
  • We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process.
  • For more information on the field safety notice (outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update
  • If you are a patient who has been affected by this field safety notice, do not try to remove the foam from your device. Doing this could affect the prescribed therapy and may void the warranty. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly.

  Which devices are affected?

  • The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices.
  • The affected products are identified in the tables below:

  CPAP and BiLevel PAP Devices

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

  Mechanical Ventilators

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

  What products are not affected and why?

  Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. You can find the list of products that are not affected here.
  

  Are there any updates regarding patient safety?

  • The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). As a result, testing and assessments have been carried out.

    Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.  This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Further testing and analysis is ongoing.

  What devices have you already begun to repair/replace?

  • In most markets, devices currently authorised for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices.
  • With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the field safety notice. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available.

• For patients (5)

  For patients (5)

  How do I know if my device is affected?

  • The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices.
  • The affected products are identified in the tables below:

  CPAP and BiLevel PAP Devices

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

  Mechanical Ventilators

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

  If my device is affected, what do I do?

  We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device.
  

  What is the safety issue with the device?

  • The issue is with the foam in the device that is used to reduce sound and vibration. In some cases, this foam showed signs of degradation (damage) and chemical emissions. This is a potential risk to health.
  • The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). As a result, testing and assessments have been carried out.
  • It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.  This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the field safety notice. Further testing and analysis is ongoing. Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation.

  Can I trust the new foam? How are you removing the old foam safely?

  • We know how important it is to feel confident that your therapy device is safe to use. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam^*. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them.
  • This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorised as part of our remediation.
  • When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them.  Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly.
  • If you are a patient who has been affected by this field safety notice, please do not try to remove the foam from your device. This could affect the prescribed therapy and may void the warranty.

    ^*Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam.

  I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back

  • We understand that any change to your therapy device can feel significant. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use.
  • The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium colour touchscreen with fewer panes to navigate. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing.
  • As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. Please review the DreamStation 2 Setup and Use video for help on getting started.

• For business customers (5)

  For business customers (5)

  What is the cause of the issue?

  Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio.
  

  How long will it take to fix the issue?

  • We expect that we will have completed over 90% of the production and shipments to customers in 2022.
  • We understand that this is frustrating and concerning for patients. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. We will share regular updates with all those who have registered a device.

  Are you still taking new orders for affected products?

  We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice.
  

  Are spare parts currently part of the ship hold?

  • Spare parts are not currently affected by the ship hold, though there may be some limited exceptions.
  • For example, spare parts that include the sound abatement foam are on hold.

  When can Trilogy Preventative Maintenance be completed?

  • Preventive maintenance for Trilogy has been paused until the new silicone foam is authorised and available.
  • The Trilogy, as well as the components containing PE-PUR foam, have all been placed on hold, for potential risks as outlined in the sound abatement foam recall 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.
  • Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement.  During these preventative maintenance periods, the service requires replacement of the PE-PUR foam components. Therefore, PM service cannot be completed until we have authorisation for the new foam design with Trilogy.
  • Please contact your Philips account manager if your Trilogy 100/200 devices require servicing during the remediation period, to discuss options.

• For clinicians (5)

  For clinicians (5)

  How many patients are affected by this issue?

  We estimate that between 3 and 4 million patients are affected, half of whom are in the U.S.
  

  What is the safety issue with the device?

  • The issue is with the foam in the device that is used to reduce sound and vibration. In some cases, this foam showed signs of degradation (damage) and chemical emissions. This is a potential risk to health.
  • The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). As a result, testing and assessments have been carried out. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.
  • It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.  This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Further testing and analysis is ongoing Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation.

  What is the risk for patients?

  • Examples of potential risks include exposure to degraded sound abatement foam particles or exposure to chemical emissions from the sound abatement form material.
  • Our quality management system processes and analyis of user reports have indicated that this material may lead to patient harm and impact clinical care.
  • While there have been limited reports of headache, upper airway irritation, cough, chest pressure and sinus infection that may have been associated with the foam, based on lab testing and evaluations, it may be possible that these potential health risks could result in a wide range of potential patient impact. These could include transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment.

  What are you doing to fix the issue?

  To resolve this situation as quickly as we can, we are doing the following:

  • Working to reach everyone affected so they understand the situation and know what they need to do, starting with the registration of the affected devices.
    
  • Frequently updating everyone on what they need to know and do, including updates on our improved processes.
    
  • Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices.
    

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

  • Patients who are concerned should check to see if their device is affected. The list of affected devices can be found here.
    
  • If their device is affected, they should start the registration process here. All patients who register their details will be provided with regular updates.
    
  • We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
    

The following products listed are affected by the field safety notice:

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

(Emergency Use Authorisation)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series S/T, AVAPS

Also known as​ System One BiPAP AVAPS (C-Series), ​System One BiPAP S/T (C-Series)​​​

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

System One 50 series

CPAPs, Auto CPAP, BiPAPs​

System One 60 series

CPAPs, Auto CPAP, BiPAPs​

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500 ​CPAP, Auto CPAP

(not marketed in US)​

If your device is affected...

Mechanical Ventilators

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

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

Also known as ​BiPAP Hybrid A30​Ventilator​ (A-Series)​
(not marketed in US)

A-Series BiPAP V30 Auto Ventilator

Also known as​ BiPAP V30 Auto​ Ventilator ​(A-Series)

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

If your device is affected...

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

• M-Series

• Trilogy Evo OBM

• Trilogy EV300

• Trilogy 202

• A-Series Pro and EFL

• DreamStation 2

• Omnilab (original based on Harmony 2)

• Dorma 100, Dorma 200, & REMStar SE

• V60 Ventilator

• V60 Plus Ventilator

• V680 Ventilator

• All oxygen concentrators, respiratory drug delivery products, airway clearance products.

By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein.

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Source: https://www.philips.co.uk/healthcare/e/sleep/communications/src-update

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