Philips : Respironics field action – FAQ – 30 January, 2023

Philips Respironics field safety notice announced on June 14, 2021

Frequently Asked Questions - as of January 30, 2023

General

What is the component quality issue in certain of Philips Respironics sleep and respiratory care products?

In 2021, Philips Respironics determined from user reports and initial testing that there are possible risks to users related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and mechanical ventilator devices. Following the issuance of the field safety notice in June 2021, Philips Respironics initiated a global program to remediate the affected devices through a replacement or repair.

Together with five independent certified testing laboratories and qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. Philips Respironics provided test result updateson December 23, 2021, June 28, 2022, and on December 21, 2022. Based on the comprehensive testing and analysis that has been done over the past 18 months, Philips Respironics now has a complete set of results for the first-generation DreamStation devices. Further testing is still ongoing and results are expected in the coming months.

Which sleep and respiratory care products are affected by the field safety notice? The affected 18 CPAP, BiPAP and mechanical ventilator products can be found atwww.philips.com/src-update. The products can be grouped in five device categories by their air path design. The first-generationDreamStation devices are the largest device category, representing approximately 68% of the registered affected devices globally.

Did the first-generation DreamStation devices follow industry standards?

The first-generation DreamStation devices were designed to meet all relevant standards at the time of development and launch and have been marketed pursuant to the relevant regulations. The devices were commercially launched in 2016.

Where can I find more information on the field safety notice?

More information on the field safety notice can be found at www.philips.com/src-update.

Was Philips Respironics aware of issues and concerns related to potential foam degradation and/or Volatile Organic Compound (VOC) emissions prior to 2021?

In prior years, there were limited complaints related to foam degradation, which Philips' subsidiary Philips Respironics evaluated and addressed on a case-by-case basis. Potential concerns relating to the emission of volatile organic compounds began to surface only more recently. When Philips became aware of the issue and its potential significance in early 2021, actions were taken leading to the field safety notice in June of 2021.

Can you comment on the FDA's notification regarding the Philips Medical Device Reports update for this field safety notice?

It is important to note that the submission of an MDRitself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of technical malfunction, serious injury or death.

At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following Philips' public statements on the issue and possible risks to users in April 2021, and the announcement of the field safety notice in June 2021, Philips Respironics received a sharp increase in complaints allegedly associated with possible foam degradation.

This resulted in a steep increase by more than 20,000 Medical Device Reports (MDRs) filed by Philips Respironics to the FDA between April 2021 and April 2022. In the following 6 months through October 2022, Philips Respironics filed an additional approximately 70,000 MDRs. The vast majority (93%) of these approximately 90,000 MDRs are alleged technical malfunctions that do not involve serious injury.

Medical Device Reports related to this field safety notice indicate reports of 260 deaths associated with reported or suspected foam breakdown in the devices. How does Philips explain this?

There have been more than 90,000 MDRs filed by Philips Respironics to the FDA from April 2021 up to and including October 2022, 93 percent of which are related to technical malfunctions that do not involve serious injury. Among the remaining reports, it is important to note that the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of technical malfunction, serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in the MDRs.

The recently completed test results indicate exposure to particulate matter from degraded foam in the first-generation DreamStation devices is unlikely to result in appreciable harm to patients. Further, the test results indicate that exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients.

Independent of Philips Respironics' test and research program, clinical researchers in several countries have been examining the data of existing sleep therapy patient studies to assess the association of elevated cancer risk when using Positive Air Pressure (PAP) devices to treat obstructive sleep apnea. They have examined the data and found no statistical increase in cancer risk due to use of Positive Air Pressure devices, including those of Philips Respironics.

For example, an analysis was published in the American Journal of Respiratory and Critical Care Medicine that found no significant difference in the risk of incident cancer among obstructive sleep apnea patients who used a Philips Respironics PAP device as compared with OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment. The analysis and conclusion were based on data from a large multi-center cohort study in Canada involving approximately 7,000 OSA patients on PAP devices between 2012 and 2020, including approximately 1,200 Philips Respironics PAP users, with a median follow-up time of 7.5 years.

More recently, an analysis was published in the European Respiratory Journal that concluded that sustained and adherent CPAP therapy of obstructive sleep apnea using Philips Respironics devices, compared with other manufacturers' devices, was not associated with an increased risk of cancer. This analysis and conclusion were based on data from a large multi-center cohort study in France involving approximately 4,500 obstructive sleep apnea patients on CPAP devices between 2007 and 2018, including approximately 1,700 Philips Respironics CPAP users, with a median follow-up time of 7.2 years.

What does the previously announced field action provision relate to?

The provision is related to the cost to repair or replace affected devices and includes the cost of intensified communication with physicians and patients, labor cost and logistics. The provision does not include any product liability costs.

Test and research program

Why has Philips Respironics been conduction a test and research program?

Together with five independent certified testing laboratories and qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds.

Philips Respironics provided test result updateson December 23, 2021, June 28, 2022, and on December 21, 2022. Based on the comprehensive testing and analysis that Philips has done over the past 18 months, the company now has a complete set of results for the first-generation DreamStation devices. Further testing is still ongoing and results are expected in the coming months.

Following the latest testing results, is Philips Respironics now excluding the health risk of possible carcinogenic effects?

The extensive data and results now available for the first-generation DreamStation devices indicate that the occurrence of visible foam degradation is low and volatile organic compounds and particulate emissions related to foam degradation are within the applicable safety limits.

The new results indicate that exposure to particulate matter (PM) emissions from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients, and that the exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients.

Based on the new test results for the first-generation DreamStation devices, is Philips Respironics now saying they are safe for patients to use?

Philips Respironics has not completed all of the testing. The December 21, 2022, update primarily relates to the first-generation DreamStation devices, and testing is ongoing related to ozone cleaning, as well as for the System One and DreamStation Go sleep therapy devices.

The extensive data and results now available for the first-generation DreamStation devices indicate that the occurrence of visible foam degradation is low and test results for volatile organic compounds and particulate emissions related to foam degradation are within the applicable safety limits.

The guidance for healthcare providers and patients remains unchanged. Philips Respironics is focused on making sure patients and their clinicians have all the information they need. As always, Philips Respironics advises patients to consult their physician or health care provider should they intend to make any changes to their therapy.

Why is the Field Safety Notice unchanged if the testing results are favorable?

The field safety notice relates to all affected CPAP and BiPAP devices. Philips Respironics is in the process of completing the tests for the DreamStation Go and SystemOne sleep therapy devices.

How did the mischaracterization and misidentification of the VOC compounds occur in the first place?

There were initially very limited test results. The additional test results delivered new insights, and data to date, including tests conducted prior to June 2021, were carefully reviewed and re-assessed.

At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Out of an abundance of caution, a reasonable worst-case scenario was considered. At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer.

Since then, together with five independent, certified testing laboratories in the US and Europe and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. This also includes an in-depth review and re-assessment of data and toxicological risk- assessments prior to June 2021.

Can you reconcile the failed genotoxicity test with the latest results published today?

Lab-agedfirst-generation DreamStation foam failed ISO 10993 genotoxicity testing under laboratory conditions, and therefore a follow-up weight of evidence assessment was conducted, per the ISO 10993 standard, to provide a confirmed conclusion on potential risks for patient under the expected usage.

To support the full toxicological risk assessment, additional chemical characterization (extractables and leachables testing) as recommended by the ISO 10993 standard was conducted to determine the identity and amount of chemicals in lab-aged and used foam samples. A third-party risk assessment of the extractables and leachables testing results concluded that there was no appreciable harm to health in patients even with conservative assumptions for exposure (e.g., patient contacted 100% of the foam in the device).

When can we expect the results for Trilogy 100/200 and other ventilator devices?

Philips Respironics continues with the remaining VOC and PM testing, as well as chemical evaluation and toxicological risk assessment for the Trilogy 100/200 (representing approximately 3% of the registered affected devices) and OmniLab Advanced Plus ventilator devices (representing approximately 2% of the registered affected devices), that contain a different type of PE-PUR foam than the first-generation DreamStation devices. Further testing is still ongoing and results are expected in the coming months.

Can you comment on the failed test for the Trilogy devices?

New Trilogy 100/200 devices passed VOC and PM testing to date. New Trilogy 100/200 foam passed ISO 10993 cytotoxicity, irritation, and sensitization testing. New and Lab-aged Trilogy 100/200 foam failed ISO 10993 genotoxicity testing under laboratory conditions, and therefore a weight of evidence assessment is ongoing to provide a confirmed conclusion on potential risks for patients under the expected usage.

Similar to the analyses performed for the first-generation DreamStation foam, additional chemical characterization as well as experiments to assess the probability and amount of degraded PE-PUR foam that can potentially reach the patient are being conducted to support the full toxicological risk assessment. The Trilogy 100/200 devices contain a different type of PE-PUR sound abatement foam. The known differences between the DreamStation foam and the foam for the Trilogy 100/200, are that the latter can be used with an acrylic pressure sensitive adhesive, has a lower density, has a different thickness, and also contains an additive to reduce potential flammability.

Why is testing taking so much time?

The test and research program involves hundreds of very time-consuming tests. Philips Respironics is doing multiple tests to assure confidence in the results. Philips Respironics is running comprehensive testing by product category, and for each product category, it is investigating three types of situations: new devices, devices with lab-aged foam, and used devices. The time taken to test and analyze the data per product category and situation is substantial and impacts throughput time for each test. The complexity of the test results also adds to the throughput time.

When does Philips Respironics expect to provide the next update on testing results?

Further testing is still ongoing and results are expected in the coming months.

Did Philips Respironics run additional testing on the silicone foam as requested by the FDA? In November 2021, the FDArequestedthat Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by silicone-basedfoam. Philips Respironics engaged independent testing laboratories to perform additional VOC testing. Based on the final reports subject to FDA review, Philips Respironics has not identified any safety issues.

Which remaining test results will Philips announce and when are these results expected? Philips Respironics is in the process of completing various other tests. As mentioned above, the toxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in first generation DreamStation devices is being finalized. Next to this, testing for the SystemOne sleep therapy devices (approximately 26% of the registered devices globally) and DreamStation Go (approximately 1% of the registered devices globally) that contain the same PE-PURfoam as the first-generationDreamStation devices is in progress.

Additionally, for the Trilogy 100/200 (approximately 3% of the registered devices globally) and OmniLab Advanced Plus ventilator devices (approximately 2% of the registered devices globally) VOC and PM testing continues, as well as chemical evaluation and toxicological risk assessment. These devices contain a different type of PE-PUR foam than the first-generation DreamStation devices.