Philips Respironics Dorma 500

Q.Why is Philips issuing a recall notification for certain CPAP, BiLevel PAP and
mechanical ventilators?
A.? On April 26, 2021, Philips provided an important update regarding proactive efforts
to address identified issues with a component in certain products of our Sleep and
Respiratory Care portfolio.
? At that time, out of an abundance of caution and based on available information,
Philips advised of potential health risks related to sound abatement foam used in
specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway
Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company also
indicated that analysis of potential health risks was ongoing, and that further
information would be provided when available.
? As a result of extensive ongoing analysis following this announcement, on
June 14, 2021, the company issued a recall notification for specific affected devices.
? The recall 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.
? To date, Philips has received a limited number of reports of possible patient impact
due to foam degradation, and no reports to date regarding patient impact related to
chemical emissions. The company continues to monitor reports of potential safety
issues as required by medical device regulations and laws in the markets in which we
operate.
? The recall notification advises patients and customers to take the following actions:
– For patients using BiLevel PAP and CPAP devices: Discontinue use of affected
units and consult with physicians to determine the benefits of continuing
therapy and potential risks.
– 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.
? 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.

Q.What devices are affected by the recall notification?
A.? The recall notification provides customers with information on how to identify
affected products.
? Additionally, the device Instructions for Use provide product identification
information to assist with this activity.

Q.What products are not affected and why?
A.? 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.

Q. Are affected devices safe for use? Should affected devices be removed
from service?
A.? The recall notification advises patients and customers to take the following actions:
– For patients using BiLevel PAP and CPAP devices: Discontinue use of
affected units and consult with physicians to determine the benefits of
continuing therapy and potential risks.
– 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.

Q. What is the safety hazard associated with this issue? Has Philips received any
reports of patient harm due to this issue?
A.? The recall 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.
Philips continues to monitor reports of potential safety issues through our postmarket 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 effects.
? To date, Philips Respironics has 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 has 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.
? To date, Philips has not received reports of patient impact or serious harm as a
result of this issue.