[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[hegel]

"Actually it would be extremely hard to find a single recalled machine that can be proven to be free of foam degradation. Philips has warned that not seeing particles is not evidence that the degradation has not occurred.

It is far, far closer to the truth to say that the foam degrades in all cases than to say that it degrades in some cases."

Again: how can you possibly know this? It's pure speculation on your part, pulled from thin air.

Bobbie, Sam isn't saying that foam degradation 'may' happen. PR says this. Sam is saying that every single machine has been issuing a constant stream of carcinogenic particles since day one of its operation. He's saying this IS happening.

What Qwerty writes is true. Foam has degraded and it's frightening. I've also read on this thread that people have opened their machines and found the foam to be intact.
My point has never been that this can't happen--clearly it does. After all, this is a class 2 recall, which is serious. My point is that we don't know the extent of the problem. People are rightly worried about their machines. Adding a lot of unproven and unlikely nightmare scenarios only brings more stress.

I stand behind my statement. PR makes medical grade machines. These have to meet regulators specifications. the foam has to meet those same specs in order to be installed in the machines. Obviously, something was missed! But Sam claiming that regulators have missed carcinogenic particles being emitted in a constant stream since 1993, worldwide, in machines that aid breathing, seems incredible. Sam's 'proof' struck me as being pretty darn weak--no proof at all. It had nothing to do with pre pur foam in these machines.

"I do not understand why you think proof is needed for saying something MAY happen. " fine. It MAY happen that I'll be struck by lightning or eaten by a bear. Should I assume that it will every time I go out of my house? No.

It would be irresponsible for me to post that there are millions of unreported cases of people falling from Half Dome on a forum for people who have a fear of heights. That's what some here are doing.

[btreger]

Some of these posts remind me of the movie, "Groundhog Day", they just get re-repeated over and over.

Several weeks ago I went through the painstaking process that allows Class II medical manufactures to get their products manufactured. I want to make this clear, Philips is not alone, most if not all are allowed by the FDA to simply fill out some paperwork referencing an earlier product that was cleared as a (Predicate).

Under this process, Philips did not have to submit clinical testing results. Of course, Philips knew exactly what kind of foam they were going to use. Years of design and testing went into the production process. The FDA has allowed this to happen, and until it is fixed it will keep happening. This particular industry needs to have independent third-party testing. Too many lives and health are at stake.

[btreger]

RE: > My post # 1029-Regarding Truckers<

After I posted the article I used in the post, it occurred to me that there were many more critical occupations that could be affected by this recall. SoI will list the ones that came to me. I am sure you can easily add to this list.

• Pilots (Both Commercial and Military)
  
• Surgeons 
  
• Fire Fighters (It seems that these fires are burning everywhere)
  
• Bus Drivers (Think about that the next time you put your child on a school bus)
  
• Cargo Ship Captains (This would include Military Ships)
  
• Ambulance Drivers 
  
• Cab Drivers (Uber and Lyft)
  
• Train Engineers (Passenger and Freight)
  
• Local Police and Fire Departments
  
• The person driving next to you on the highway
  

[btreger]

This is for those of you who are considering stopping or have already stopped using your recalled CPAP machines.

Sleep Apnea Doubles Odds for Sudden Death
By Steven Reinberg
HealthDay Reporter
TUESDAY, Aug. 3, 2021 (HealthDay News)

The condition — in which a person's airway is repeatedly blocked during sleep, causing pauses in breathing — may also increase the risk for high blood pressure, coronary artery disease, and congestive heart failure, new research shows.

A team at Penn State University reviewed 22 studies that included more than 42,000 patients worldwide. Their review revealed that people with obstructive sleep apnea had a greater risk of dying suddenly and the risk rose as patients aged.

"Our research shows this condition can be life-threatening," principal investigator Anna Ssentongo said in a university news release. She's an assistant professor and epidemiologist at Penn State.

The repeated lapses in breathing in sleep apnea cut off the oxygen supply to cells, which can result in an imbalance of antioxidants in the body. This imbalance harms cells and may speed up the aging process, leading to many health problems, the researchers said.

[WakeUpTime]

I think you're all pushing fears that aren't justified and many who read your posts will freak out unnecessarily. That/'s why I don't get lost, but it's wearying and I may, out of exhaustion.  I don't use a recalled PR machine. 

That philosophy reminds me of a relative of mine who gets hired for new product research testing.  She willingly goes along with anything a company puts in her glass, because "it must be safe".

Hypothetically, let's imagine there is a new flavor of Gatorade that has RoundUp as an ingredient.  One could make the argument that it's never been proven that Gatorade with RoundUp is harmful, even though most wouldn't consider drinking it.  Gatorade may have even done it's own testing to show that no one got sick immediately after drinking their new product.  They may not even have had any "registered complaints" about the new product.  It's an imaginary scenario to highlight that companies don't long-term fully test their products in a variety of usage situations. 

Let's not forget that product approvals are usually given based on existing research that the submitting company has done, rather than the product being long-term tested by the government or other medical agencies.

Let's be respectful of the "advisory" comments made by actual device users and owners.

[BobbieM]

I’ve concluded from reading most of the posts that it is the FDA that should be recalled.

[BHappy]

Just read about the recall notice.
I am now starting the believe the whirring noise that a lot of people experience could be because of the foam. It started on my machine a year ago : http://www.apneaboard.com/forums/Thread-...-Australia
Now I wonder why I have been getting so many colds and respiratory infections despite living an ever healthier lifestyle. Was chalking it up to age.
So are users from the rest of the world stuffed? I bought it from a seller in the US (supplier#2) and use it in Australia. Called their 1800 number on 1800-009 579 and the operator has "no clue what is going to happen or even what is happening" !?!?!?!

[hegel]

What's the likelihood of Gatorade using Roundup in their drinks and selling it on the market? And moreover...what's the likelihood that no one would notice Roundup in Gatorade for decades?

Zero. we have basic food safety standards. This could never happen.

[WakeUpTime]

Now I wonder why I have been getting so many colds and respiratory infections despite living an ever healthier lifestyle.  I bought it from a seller in the US (supplier#2) and use it in Australia. 

Welcome to the thread, and being part of the group of recalled device owners.  There are 3-4 million other recalled device owners who are also struggling with news of the recall and Philips' lack of any responsive actions (or answers) so far.

Starting from the beginning, I'm assuming that your recalled device was a second-hand purchase, given that it was purchased from Supplier #2.  As we know, the use of SoClean (or similar ozone internal system cleaning products) speeds the breakdown of the Philips faulty foam. 

If you have been a SoClean user, that would expedite the breakdown of foam.  If Supplier #2 used SoClean to disinfect their devices as part of its significant cleaning of its refurbished systems, that could also be a factor.  Lastly, we don't know if the previous owner of your device was a SoClean (or similar) product user.  (We also know there are additional factors that expedite the breakdown of foam particles, such as high heat and humidity.)

If I were in your shoes, as a result of those SoClean unknowns, and your subsequent illnesses, I'd be extremely curious of the current state of my foam inside my recalled DreamStation.  That would give me evidence as to the possibility that I had been ingesting an above average amount of foam particles.  Recalled device owners are somewhat stuck between a rock and a hard place. 

Very few will ever know the state of their existing foam in their recalled device,

indicating their degree of foam degradation and likely ingestion,

after they eventually release it to Philips for their fix or replacement.  

There are class-actions lawsuits in process in the U.S.  Canada has one as well.  I'm not sure about Australia.  I'd contact one of those law firms and ask them for advice.  If I were one of those law firms, I'd advise NOT returning the existing foam to Philips, knowing that you've had those subsequent health issues after using your recalled Philips second-hand device.  I'd consider removing it (or having someone do that) and storing it, but recording the process for integrity's sake.  

Because you're in Australia, with a U.S. purchased product, I'm not sure how Philips views you.  Will Philips allow you to get your product fixed/replaced in Australia, or will they make all of us go through their place of purchase (the DME)?  Sadly, Philips will probably say they "don't know yet" and your U.S. DME is saying they don't know either.  

Since we don't actually register our new Philips device purchase with Philips directly, I would think that it doesn't matter if you were the first or second owner of your recalled Philips device.  They likely wouldn't know either way.  At best, Philips might know where your device was initially shipped, but hopefully none of that will inhibit their fixing/replacing your recalled device.

So your immediate options seem to be to use an in-line anti-bacterial filter, get a replacement device (which can be very costly for some without insurance), or keep using their machine as-is, knowing that it could be 12 months or more before Philips provides a fix or replacement.

As one last idea, please consider searching this thread to seek out other recalled device owners in Australia.  Consider messaging them to see if Philips Australia is offering anything unique for its local market.  Maybe you all could keep each other updated on recall events (and recall news) specific to device owners in Australia.  Just a thought.

I'm so sorry for what you must be going through right now.

[BHappy]

Starting from the beginning, I'm assuming that your recalled device was a second-hand purchase, given that it was purchased from Supplier #2.  As we know, the use of SoClean (or similar ozone internal system cleaning products) speeds the breakdown of the Philips faulty foam. 

Thank you for replying. I bought it brand new from supplier 2 and I have never exposed the machine to a commercial cleaner at all. Just warm water and dish soap for the mask, humidifier, tube and regular replacing of filters.