FDA will not change recommendations related to previous safety communication regarding Philips Respironics recalled ventilators; initial recall in June 2021 occurred due to potential health risks of BiPAP and CPAP machines

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WASHINGTON , March 14, 2022 (press release) –

 

The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the prior safety communication. This update also addresses common questions and concerns from consumers, patient organizations, and health care professional societies. As the FDA continues to work diligently on this recall and develop solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers.

In June 2021, Philips Respironics recalled certain ventilators, BiPAP, and CPAP machines (see table below) because of potential health risks. The polyester-based polyurethane foam used in these devices to reduce sound and vibration can breakdown. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, which can be life-threatening and require medical intervention to prevent permanent injury. The foam issue may get worse in hot and humid settings, and by using ozone cleaners or other cleaning methods not recommended by the manufacturer.

Recalled Devices
If you use one of these recalled devices, follow the recommendations listed below.

Philips Respironics is recalling the following devices made between 2009 and April 26, 2021.

A-Series BiPAP A30
A-Series BiPAP A40 (ventilator)
A-Series BiPAP Hybrid A30
A-Series BiPAP V30 Auto (ventilator)
C-Series ASV (ventilator)
C-Series S/T and AVAPS
DreamStation
DreamStation ASV
DreamStation Go
DreamStation ST, AVAPS
Dorma 400
Dorma 500
E30
Garbin Plus, Aeris, LifeVent (ventilator)
OmniLab Advanced+
REMstar SE Auto
SystemOne ASV4
SystemOne (Q-Series)
Trilogy 100 (ventilator)
Trilogy 200 (ventilator)
Philips Respironics is also recalling certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. 

Recalled BiPAP or CPAP:
Recommendations for People Who Use Recalled BiPAP or CPAP Machines and Caregivers
Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Your provider may advise you to:
Stop using your recalled device (see How to Know if You Should Stop Using Your Device in Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions).
Use another similar device that is not a part of this recall.
Continue to use your recalled device, if you and your health care provider decide that the benefits of using it outweigh the potential health risks listed below.
Use other treatments for sleep apnea, such as:
Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back.
Oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
Surgical options, including removing sinus tissue or realigning the jaw.
Make lifestyle changes, such as:
Lose weight 
Avoid alcohol
Stop smoking
Follow Philips Respironics' instructions for recommended cleaning of your CPAP machine and accessories.
Do not use ozone or ultraviolet (UV) light cleaners. Ozone cleaners may breakdown the foam, even if you do not see the pieces of foam in the air tubes, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
Register your device(s) on Philips Respironics' recall websiteExternal Link Disclaimer. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing registration on the Philips Respironics' online patient portalExternal Link Disclaimer and provide additional information. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips Respironics. If you do not provide the additional requested information, you will receive a replacement device based on when you registered. You may also check the status of your replacement device on Philips Respironics' online patient portalExternal Link Disclaimer. For Spanish, Iniciar proceso de registroExternal Link Disclaimer.
Do not use an additional filter with a CPAP or BiPAP machine.
Do not try to remove the foam from your device. Trying to or successfully removing the foam may damage the device or change how the device works. It may also lead to more foam or chemicals entering the air tubing of the device.
If you have a health issue, including those listed below, or any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.
Repaired and Replaced BiPAP or CPAP:
Recommendations for People Who Use BiPAP or CPAP Machines Replaced by Philips Respironics and Caregivers
Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs).
Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results.
The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.
Continue to use your repaired/replaced device.
If you have additional concerns, talk to your health care provider about the plan for your care and treatment.
The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients.
Recalled Ventilators
Recommendations for People Who Use Recalled Ventilators at Home and Caregivers
Do not stop or change ventilator use until you have talked to your health care provider, such as your primary doctor.
Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of foam, as indicated in the Philips Respironics recall notification. At this time, the FDA is still evaluating a filter and does not yet have proof that a filter can reduce the foam's risks. The FDA's evaluation is ongoing. It is important to note the following considerations:
Filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam.
Filters may make the ventilator work less well because they may increase resistance of air flow through the device.
If your ventilator has a bacterial filter, closely monitor for foam pieces collecting on the filter or airflow problems.
Register your device(s) on Philips Respironics' recall websiteExternal Link Disclaimer and provide important additional information to facilitate replacement of your device and to get updated information from Philips Respironics. For Spanish, Iniciar proceso de registroExternal Link Disclaimer.
If you have a health issue, including those listed below, or any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.
Recommendations for Health Care Providers and Facilities
Follow the recommendations above for the recalled devices used in health care settings.
Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device.
If you treat a patient who has a health issue, including those listed below, or have any problem with a device, report the problem through the MedWatch Voluntary Reporting Form.
Description of the Devices
The devices are used to help breathing. Three main types of device have been recalled:

A continuous positive airway pressure (CPAP) machine keeps your airway open by providing a stream of air at a continuous pressure through a mask. CPAP machines are often prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
A bilevel positive airway pressure (also known as BiPAP, BiLevel PAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. BiPAP machines use a higher pressure when you breathe in and lower pressure when you breathe out.
A continuous ventilator device mechanically controls or helps patients' breathing while delivering a set amount of oxygen.
Potential Health Risks from Sound Abatement Foam
Polyester-based polyurethane (PE-PUR) foam is used to lessen sound and vibration in these devices and other medical equipment. This particular foam may breakdown and can result in serious injury, which can be life-threatening, cause permanent impairment and require medical intervention to prevent permanent injury to users:

Breakdown (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user.
Release certain dangerous chemicals, such as volatile organic compounds (VOCs), into the device's air tubes, and be inhaled by the user.
The foam damage may get worse in hot and humid settings, and by use of unapproved cleaning methods, such as ozone cleaners and ultraviolet (UV) light products.
If the foam breaks down, you may or may not see black pieces of the foam in the air tubes or masks.

The potential risks of particulate exposure inhaling or swallowing pieces of foam include:

Irritation to the skin, eyes, nose, and respiratory tract (airway)
Inflammatory response
Headache
Asthma
Toxic or cancer-causing effects to organs, such as kidneys and liver
The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include:

Headache
Dizziness
Irritation in the eyes, nose, respiratory tract (airway), and skin
Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
Nausea or vomiting
Toxic and cancer-causing effects
Between 2014-April 2021, Philips Respironics submitted 30 MDRs (eight from the U.S.) they identified as related to foam breakdown (degradation).

The FDA did not receive any MDRs reporting patient injury or harm related to foam breakdown (degradation) prior to Philips Respironics notifying the agency of their intention to conduct a field action in April 2021.

Since April 2021, the FDA has received over 3,000 MDRs related to foam breakdown (degradation). A wide range of adverse events have been reported to the FDA, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 

Silicone-based foam: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program.

Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment.

The FDA has not received reports of death related to these issues.

FDA Actions
On March 14, 2022, the FDA updated its Frequently Asked Questions about the Philips Respironics CPAP, BiPAP, and ventilator recall to include information about Philips Respironics' prioritization strategy for replacement devices. The FDA shared with Philips Respironics the concerns of health care providers and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health. A first-come, first-served replacement strategy may not address these risks, or the risks from continued use of the recalled devices that such patients may face.

For people with a recalled device: Philips Respironics' online patient portalExternal Link Disclaimer now allows you to provide additional information for prioritized replacement and to check the status of your replacement device.

For more information about the status of your replacement device or to update your record with prioritization information, go to the Philips Respironics' online patient portalExternal Link Disclaimer or call 1-877-907-7508.

On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company's June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company's notification efforts to date have been inadequate. For more information about the order, see the FDA's March 2022 press release.

On January 26, 2022, the FDA provided an update related to the recall of certain Philips Respironics ventilators. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. The FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. For more information, please see Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam. 

The FDA conducted an inspection, completed in November 2021, of a Philips Respironics' manufacturing facility to determine what may have caused or contributed to the foam issues and to assess adherence to the agency's requirements for quality manufacturing. The FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality. During the inspection, the FDA investigator made several observations that are outlined in an inspection closeout report, also known as an "FDA Form 483." The FDA investigator provided a list of their observations to the company. An FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. The FDA is carefully evaluating the findings of the inspection, the company's response to the inspectional observations, and the totality of information available to the agency in determining appropriate next steps.

The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam used in the repair and replace program.

The agency recognizes that many patients will have questions about what this information means for the status of their devices. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc. and the American Academy of Sleep Medicine, and has included this feedback in the updated Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions. For more information on actions the FDA is taking and has taken, see the FDA's November 2021 press release.

Reporting Problems with Your Device
If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?
The FDA posted answers to frequently asked questions about this recall: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions.

For more information on the company's recall notification, contact your local Philips Respironics representative or visit Philips Respironics' recall notification web pageExternal Link Disclaimer.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

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