What to Know About Phillips CPAP Recall
You may have heard about the recall of Philips brand sleep apnea machines. This unfortunate situation involves 5.5 million devices, and the toxic foam inside has affected 90,000 people across the globe. If your health has been damaged by your Continuous Positive Airway Pressure (CPAP) machine, keep reading to find out how the team at De Castroverde Personal Injury & Accident Lawyers can help.
Why Did Philips Issue a Recall?
Philips is one of the largest manufacturers of CPAP machines in the world. In June 2021, the company discovered a problem with the Polyurethane foam (branded PE-PUR) used in millions of their mechanical ventilator devices. This realization led to a massive voluntary recall in the U.S. As of Feb. 2023, the company had received 98,000 medical device reports (MDRs), many documenting harm caused by the sound abatement foam. This figure includes 346 patient deaths — a number that’s increasing every month.
The toxic foam’s purpose was to reduce noise and vibration so the machine would operate quietly at night. But unfortunately, the material deteriorates and releases harmful black particles and gases called volatile organic compounds into the machines’ air pathways. The PE-PUR foam tested positive for at least five poisonous chemicals, including known carcinogens Diethylene glycol and Toluene diamine. These substances are a serious potential health risk when users inhale them directly into their lungs.
Potential Side Effects From Exposure
If you were exposed to deteriorating PE-PUR foam while using your CPAP device, you might experience various short- and long-term side effects. The list of possible symptoms includes:
- Difficulty breathing.
- Irritation of your eyes, nose, and throat.
- Nausea or vomiting.
- Chest pain.
- Persistent cough.
- Chronic asthma.
- Chronic bronchitis.
- Kidney disease.
- Liver disease.
If you’ve been exposed to harmful particles or chemical gases from your CPAP machine and are experiencing any of these symptoms, see your doctor right away. These substances can be measured in your blood and urine. However, they leave the body within a few days, so you want to run these tests as soon as possible. That way, your physician can start you on the road to recovery, and the lab results will help us build a solid personal injury case on your behalf.
Affected Philips CPAP Machines
Use this list to see if your CPAP machine is part of the recent recall. If so, Philips recommends that you stop using your machine immediately. Then, consult your doctor to discuss the best options for continued treatment. While 80% of affected machines fell within the DreamStation CPAP line, this list represents all Philips devices outfitted with toxic foam:
- DreamStation CPAP, Auto CPAP, and bilevel positive airway pressure (BiPAP) devices.
- DreamStation Adaptive-servo ventilation (ASV) devices.
- DreamStation Spontaneous Timed (S/T) and Average volume-assured pressure support (AVAPS) devices.
- DreamStation GO (CPAP and APAP).
- Dorma 400 and 500 (CPAP).
- C Series (ASV, S/T, and AVAPS).
- REMStar SE Auto (CPAP).
- SystemOne (ASV4).
- SystemOne (Q Series).
- E30 (Emergency Use Authorization).
- Trilogy 100 Ventilator.
- Trilogy 200 Ventilator.
- OmniLab Advanced Plus (In-lab Titration Device).
- Garbin Plus, Aeris, LifeVent Ventilator.
- A-Series BiPAP V30 Auto Ventilator.
Philips CPAP Recall Updates
A lot has happened since 2021 when Philips realized that its CPAP machines released toxic foam particles and chemical gases. Once patients started suffering everything from minor respiratory issues to life-threatening conditions, such as cancer, the news of the recall spread. Consequently, complaints that the manufacturer’s defective design was putting people at risk flooded the courts. In fact, anyone under 80 who used a recalled Philips device and has suffered health problems may qualify for compensation. There is a statute of limitations on personal injury claims, however. So you’ll need to act fast if it affects you.
What has Philips done about the issue in the last two years? First, the manufacturer promised to either repair or replace any recalled machine that contained the dangerous foam in September 2021. However, the company warned consumers that the process could take up to a year to complete. In the meantime, patients should ask their doctor for an alternative sleep apnea device.
By January 2022, the list of CPAP devices grew to include all Trilogy Evo ventilators and repair kits, plus 1,660 of Philip’s BiPAP ventilators. Between April 2021 and April 2022, the manufacturer filed approximately 20,500 MDRs with the Food and Drug Administration (FDA), alleging more technical malfunctions. Then, in June 2022, the company provided the FDA with a research update indicating that its PE-PUR sound abatement foam wasn’t expected to cause any health problems. Phillips then went on to state that consumers who cleaned their devices with ozone air purification systems were 14 times more likely to damage the foam.
In October 2022, the crisis escalated to a Class I recall. This time it included 18 million magnetic CPAP and BiPAP masks. In some cases, the magnets interfered with medical implants, such as pacemakers, causing serious injury or death. Over the next two months, Philips would file another 78,800 MDRs related to its defective medical equipment with the FDA. Tragically, there were reports of another 82 deaths by New Year’s Eve.
Just two months later, the U.S. judicial panel on multi-district litigation consolidated 272 CPAP product liability cases in Pennsylvania. This February 2023 figure doesn’t include claims filed in state courts that aren’t part of a multidistrict litigation case. Phillips is also facing class-action lawsuits seeking reimbursement for the cost of a new CPAP machine, in addition to personal injury claims. These matters are in the initial stages, and no trials or settlement offers are on the table yet.
Has Philips Produced Replacement CPAPs?
Phillips is well on its way to producing replacement CPAP devices for its patients. More than 90% of the production required for the delivery is already done. The company also claims it’s spent a year and a half working with five independent certified laboratories, physicians, and third-party experts to extensively test and analyze its first-generation DreamStation devices. So while we wait for a Philips replacement, talk to your doctor about using a sleep apnea device that wasn’t affected by the recall or other ways to best care for your health.
If you’ve been injured by a Philips CPAP machine, and you’re in the areas of Reno and Las Vegas,contact De Castroverde Personal Injury & Accident Lawyers. Let our family fight for yours. Our experienced attorneys know all the ins and outs of mass tort personal injury cases, and our outstanding reputation and successful track record prove that you won’t have to settle your case for less than you deserve. We know there’s a lot at stake — and we deliver.
Photo Credit: Wide Variety of Masks at CPAP Central by Rachel Tayse is licensed with CC BY 2.0