Philips DreamStation Foam Problems Were Disclosed To Investors Before Users Were Warned to Stop Using CPAP Machines

Weeks before consumers were told to immediately stop using Philips DreamStation CPAP and BiPAP machines, which may be causing them to inhale or ingest toxic materials, the manufacturer provided information about the potential risks to investors, indicating it had already developed a new version of the popular sleep apnea machine which did not experience the same foam degradation problems.

Koninklijke Philips, also known as Royal Philips, first announced a massive CPAP, BiPAP and ventilator machine recall on June 14, involving an estimated 3.5 million devices distributed with unsafe and defective sound abatement foam, which may degrade and release black particles or toxic chemicals directly into the air pathway.

Exposure to the toxic particles and gases released by a polyester-based polyurethane (PE-PUR) foam inside has been linked to reports of cancer, severe respiratory problems and other health complications, according to allegations raised in a growing number of Philips DreamStation lawsuits filed over the past few weeks.

However, it is becoming increasingly clear Philips knew about the foam problems with DreamStation sleep apnea machines long before it told consumers to stop using the products, yet it appears the the company prioritized profits over consumer safety by developing a new version of the popular sleep apnea machine and reassuring investors before actually disclosing the risk to individuals who were using the CPAP and BiPAP breathing machines every night.

In an quarterly earnings report (PDF) provided for investors on April 26, weeks before the recall notice was issued, the company provided information to investors about the Philips DreamStation foam problems in a subsection titled “Regulatory Update”.

Philips confirmed at that time it had determined, through user reports and its own testing, that there were possible risks related to the sound abatement foam used in the machines, but reassured investors a new “next-generation CPAP platform”, known as DreamStation 2, had been introduced a few weeks earlier, which was not affected by the issue

The report raises serious questions about why Philips waited weeks, or possibly longer, between confirming this risk and warning actual customers.

On June 30, the FDA issued a safety communication, urging consumers who were not relying on the devices for life-sustaining therapy to immediately stop using the recalled sleep apnea machines and contact their doctors to decide on alternative treatments for the condition.

For individuals reliant on recalled Philips ventilators, which provide mechanical breathing assistance that is often life-sustaining, the FDA indicates consumers should not stop using the device until they speaking with a doctor, and recommended that inline bacterial filters be used to help catch the foam particles before they enter the air pathway. However, even this may pose risks, since it is unclear whether the filters are safe or effective, and may increase the resistance of airflow through the device.

Koninklijke Philips, N.V. generated over $23 billion in revenue last year, and is expected to face massive liability from lawsuits and CPAP machine settlements over the next few years. In the earnings report issued prior to announcing the recall, the company advised investors it had taken a provision of about $295 million to cover the costs of the recall, which will likely only cover a small fraction of the compensation and damages the company will ultimately be required to pay.

8 Comments

  • MelodySeptember 22, 2021 at 1:50 pm

    The way Philips got the recall information out to consumers is disgraceful! I have been using this machine since 2017. I found out 3 days ago that it has been recalled and the only reason I found out is because I visited this website: https://www.mydreammapper.com/Home/Sleep. You would think they would have found a better way to inform their customers. Now I am going without a cpap machine. I regi[Show More]The way Philips got the recall information out to consumers is disgraceful! I have been using this machine since 2017. I found out 3 days ago that it has been recalled and the only reason I found out is because I visited this website: https://www.mydreammapper.com/Home/Sleep. You would think they would have found a better way to inform their customers. Now I am going without a cpap machine. I registered with philips and got the confirmation that more or less reads, 'we'll get to you when we get to you." But honestly, do I want another philips cpap machine? I have read that they knew about the problem with these machines before the customers were informed. So how do we know there isn't something wrong with the new machines? I do wake up with a headache more often than not and I constantly feel like I am clearing something out of my lungs. Here I am using a product that is supposed to be helping my health and now find out it could have been doing more harm all along. Who knows what damage could have been caused that won't be discovered for years to come?

  • davidSeptember 22, 2021 at 1:03 am

    A doctor trained to convince you that you're in need of a dream machine. CO2 is a high-level er level around your body as your blood O2 is dropping and respiration air diffuses above your body at night. Then you install a coss-ventilation fan as any good HVAC tech would do and your situation can be the remedy. Check your blood 0xygen at night with an alarm watch. Furthermore, it scam as Phillips[Show More]A doctor trained to convince you that you're in need of a dream machine. CO2 is a high-level er level around your body as your blood O2 is dropping and respiration air diffuses above your body at night. Then you install a coss-ventilation fan as any good HVAC tech would do and your situation can be the remedy. Check your blood 0xygen at night with an alarm watch. Furthermore, it scam as Phillips makes large machines in the emergency room that tests the respirations to the O2 which your ER can do if you're having a heart issue. I tested Ok but buy they failed to do the sleep test as I went in at night to rest see what going on and everyone rejected to look at the interior of the machine quality control. The medical and legal profession has another scam that individuals have to cancer and others. said as they look for big bucks for injury catastrophic injury. Real loser are you reading this information wondering. SCAM LEGAL AND MEDICAL TOO. Your brain needs good oxygen at night and oxygen deprivation training is not the same for sports.

  • KarenSeptember 13, 2021 at 7:17 pm

    1. I received a letter from Philips 2. I received notification from my Sleep Doctor 3. I have no gripes about being informed of this.

  • BillAugust 15, 2021 at 5:28 pm

    Now patients will find out how these big companies can do things like this without liability

  • ElaineAugust 11, 2021 at 4:31 pm

    I found out about the recall on a Facebook post. That is totally unacceptable. I should have been notified immediately by the company who distributed the machine and products to me. I have been using my machine for 4 years and depend on it. I spoke with my doctor who prescribed it to me and she said due to the severity of my apnea, I should continue to use it until it is replaced. Just this week[Show More]I found out about the recall on a Facebook post. That is totally unacceptable. I should have been notified immediately by the company who distributed the machine and products to me. I have been using my machine for 4 years and depend on it. I spoke with my doctor who prescribed it to me and she said due to the severity of my apnea, I should continue to use it until it is replaced. Just this week I went to clean my water tray and found filmy spots on the remaining water. When I touched the spots, they were black on my fingertip. Now I’m scared to continue using it.

  • wayneAugust 11, 2021 at 12:32 am

    This whole episode reeks of big companies putting profits/investors before consumers. apart from the actual physical side effects there are the mental ones as well, i purchased my machine on 28may 2021 between the initial announcement and the recall (missed the announcement) , i would not have purchased this machine if i new, still no word from phillips (even though i am registered o their data s[Show More]This whole episode reeks of big companies putting profits/investors before consumers. apart from the actual physical side effects there are the mental ones as well, i purchased my machine on 28may 2021 between the initial announcement and the recall (missed the announcement) , i would not have purchased this machine if i new, still no word from phillips (even though i am registered o their data site), i cannot get over the fact that a machine that pumps air into your airways was not initially tested for the VOC's at least. Phillips handling of the recall has been non-existent, this has the potential to be another ;Asbestos' type issue, it will be years before anyone knows about serious issues, the governments around the world need to get involved in this so a trust type fund is set up for victims, personally this has caused myself and my family a huge a amount of worry, i am not in a position to stop using the machine as i cannot function without it (other health issues potentially getting worse) its a double edged sword, regulators need to pull their fingers out and sort this mess out as well....

  • AmberJuly 29, 2021 at 10:03 am

    This is unacceptable! Millions of consumers struggling to find a replacement ( if they are lucky? to have resources) Phillips knew EXACTLY what was going on before the "voluntary recall" My RT from home medical told me Phillips was phasing out my machine and everyone would be getting a new one( end of June) the next week I see FB post about recall... Thousands of posts now regarding this issue and[Show More]This is unacceptable! Millions of consumers struggling to find a replacement ( if they are lucky? to have resources) Phillips knew EXACTLY what was going on before the "voluntary recall" My RT from home medical told me Phillips was phasing out my machine and everyone would be getting a new one( end of June) the next week I see FB post about recall... Thousands of posts now regarding this issue and maybe 2 letters to consumers from Phillips in the last week!? I called my home medical company and they had no clue until she called higher up!? UNACCEPTABLE- Phillips does not have enough $$ to pay for the evil decisions they have made playing with people's lives. And still they continue to pass the responsibility on... Who will hold them accountable? Several of the "side effects" have been looked at as part of our medical condition not realizing we were breathing in this carcenogenic materials. Cancers do not happen overnight and there is NO test to determine if you have it unless you are looking for it! This does not end w/ new machines or repairs. This will be ongoing for all of us and our families who have been exposed to these toxins without any remorse from Phillips. They should be forced to wear thier own Dreamstation$$ ( Death station is customers are now calling it)

  • MaryJuly 22, 2021 at 3:31 pm

    This is awful. Whats worst i need a machine and can't get one. I sleep two hours at a time because i am afraid to sleep with no mask. I wore mine 5 years straight and now i can't. The company will not help Class action lawemsuit because they are causing me stress.

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