Philips CPAP Machine Recall

On June 14, 2021 Royal Philips (NYSE: PHG, AEX: PHIA) issued a voluntary recall notification for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. This recall was the result of “identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component of these devices.” The Philips CPAP machine recall includes devices in the first-generation DreamStation product family.

If you were injured or a loved one died due to the side effects of using a Philips CPAP machine, you may qualify for financial compensation. The Guardian Legal Network helps victims of negligent medical device manufacturers to take legal action. We can connect you with an experienced law firm that can help you file a Philips CPAP machine claim.

What is a CPAP Machine?

Continuous positive airway pressure therapy (CPAP) helps a person with obstructive sleep apnea breathe more easily while they sleep. CPAP therapy involves a machine that works to prevent your airway from collapsing when you breathe in by increasing air pressure in your throat.

CPAP machines can have a mask that covers your mouth and nose, a mask that covers only your nose, or prongs that fit into your nose. The Philips CPAP machine recall also includes affected bilevel positive airway pressure (Bi-Level PAP) machines.

Bi-Level PAP machines have many of the same attachments and supplies as a CPAP machine, but are used to treat central sleep apnea, complex sleep apnea, or chronic obstructive pulmonary disorder (COPD).

How Does a CPAP Machine Work?

A CPAP machine works to provide continuous pressurized air through a mask that seals with your mouth or nose. Air is pushed through at a pressure just high enough to prevent the collapse of your airway. Air is taken in through a filter and pressurized according to settings prescribed by your doctor. This video describes how the CPAP machine doesn’t breathe for you, but how varying air pressures in inhalation and exhalation help users breathe more comfortably.

A key difference between a CPAP machine and a Bi-Level PAP machine is how air pressure is delivered. The CPAP machine delivers a continuous level of air pressure, while the Bi-Level PAP machine delivers two levels of air pressure on inhalation and exhalation.

Risks and Side Effects of a CPAP Machine

There are potential risks and side effects to be aware of when using a CPAP machine or Bi-Level PAP machine. Common side effects of using a CPAP machine include:

Discomfort: This can be experienced if the mask or hose are new to you, or you have the wrong size equipment.
Claustrophobia: Some users may experience this as the mask fits tightly around your nose, mouth, or both
Aerophagia: The medical term for swallowing air. This could occur if the pressure coming into the machine on inhalation is too high.
Dry Mouth or Dry Nose: Dry mouth or nose can be a side effect of each type of CPAP mask. The constant air into your airways can cause dryness.
Headaches: If the pressure is set too high, a headache can occur. This isn’t a common CPAP side effect.

More Detail About The Philips CPAP Machine Recall

The Philips CPAP machine recall occurred amid reports of health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam component within some of its devices. The PE-PUR foam is used to decrease the sound of the machine during use.

Philips observed a 0.03% complaint rate in 2020 and began testing potential risks to users related to PE-PUR foam. According to Philips, the PE-PUR foam may degrade into particles which may enter the air pathway and be ingested by the user. The degraded PE-PUR foam may off-gas certain chemicals.

The Philips CPAP machine recall specifically outlines potential risks of degraded material exposure including possible toxic and carcinogenic effects. If you are experiencing irritation, inflammation, headache, or respiratory issues, talk with your healthcare provider.

In addition to the risks of exposure to degraded material, the off-gassing may cause irritation, hypersensitivity, headache, nausea/vomiting, and possible toxic and carcinogenic effects.

The recall is specific to devices manufactured before April 26, 2021. View the list of affected Bi-Level PAP and CPAP devices, and the list of affected life-sustaining mechanical ventilator devices below:

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 (Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced Plus

Non-continuous Ventilator

SystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto

Continuous Ventilator

Trilogy 100 Ventilator
Trilogy 200 Ventilator
Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series Bi-PAP Hybrid A30 (Not marketed in U.S.)
A-Series Bi-PAP V30 Auto

Continuous Ventilator, Non-life Supporting

A-Series Bi-PAP A40 (Not marketed in U.S.)
A-Series Bi-PAP A30 (Not marketed in U.S.)

Products not affected by the Philips CPAP machine recall include those that may have different sound abatement foam materials:

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.

Are You Looking for a Defective CPAP Machine Lawyer?

If a defective Philips CPAP machine injured you or a loved one, contact The Guardian Legal Network to connect with an experienced lawyer.

Severe medical conditions may not be reversible, but an impacted individual should not be left alone to bear the costs. The Guardian Legal Network can help connect you with a Philips CPAP machine recall lawyer who will help you hold the manufacturer responsible for your injuries.

Fill out an online contact form or give us a call at (855) 968-0193 today.

References

“Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices”: https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html. Accessed June 30, 2021
“Medical Device recall notification (U.S. only) / field safety notice (International Markets)” https://www.usa.philips.com/healthcare/e/sleep/communications/src-update. Accessed June 30, 2021
“CPAP Side Effects” https://www.sleepassociation.org/sleep-apnea/cpap-treatment/cpap-side-effects/. Accessed June 30, 2021
“Video: How CPAP Controls Sleep Apnea” https://www.mayoclinic.org/diseases-conditions/sleep-apnea/multimedia/cpap/vid-20084718. Accessed June 30, 2021
“CPAP and BiPAP: Which One is Best For You?” https://www.sleepassociation.org/sleep-apnea/cpap-vs-bipap/. Accessed June 30, 2021
“Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea” https://www.uofmhealth.org/health-library/hw48752. Accessed June 30, 2021

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