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

[btreger]

It sounds like you got it covered.

Burt

[racprops]

"Probably not the best idea to use on a breathing machine, to patch up holes, either. My gut feeling is that duct tape and cutting up the same machine would void any warranty."

IF you READ my posts I clearly stated that over and over again and again/

"Thanks for the history lesson! Duck tape is good stuff. Just not a good choice for medical devices. "

Perhaps but the foam inside our machines HAS BEEN reported dangerous to have Phillips issue a DO NOT USE order.

Please read my posts before committing on them so inaccurately.

Rich

[cathyf]

The other thing that everyone should keep in the back of their minds is that this danger could be highly theoretical and isn't really a danger at all. Or it could be that ozone is a danger, but without ozone no problem. (Ozone is a HIGHLY reactive chemical. Normal room air is not...)

America is a highly litigious society, and there are people who make big $$$ bringing lawsuits, especially these class-action suits where the lawyers make tens of millions and the "victims" get a few dollars.

So before getting panicky, remember Alar...

[Ratchick]

I'm just gonna leave this example here...

At one point, some dentists and alt-med folk began to believe that certain symptoms (and eventually pretty much ALL symptoms from those of autism to cancer) were caused by the mercury amalgam in fillings. After all, mercury is toxic right? It can't be good for you to have MERCURY in your teeth. So obviously the best idea is to have the fillings removed and replaced with other kinds right?

Except that the mercury form in the fillings was not a form that is especially toxic to the human body. Very little, if any, mercury leached from the fillings, let alone into the bloodstream, and exposure from other sources (especially dietary) are far higher. And in the act of removing those fillings, especially older ones, it ended up exposing the person to far MORE harmful mercury than they would have been exposed to by leaving the fillings in place. In addition, other filling materials - especially at the time this first blew up - were nowhere near as stable, resulting in a greater risk of infections, the need for repeated repairs, and the increased likelihood of needing a root canal, crown or extraction, as well as developing tooth abscesses etc.

And guess what? Turns out mercury amalgam filling doesn't cause all those issues after all. Any increase in blood levels is minimal, insignificant compared to the usual levels that don't affect health, and significantly below accepted levels. In fact, the vast majority of leaching happens at two points - when placing the filling, and when removing them. Acting rashly and removing the old fillings ended up exposing them to far more mercury than a lifetime of leaving them in.

Can mercury cause severe and potentially deadly health issues? Yep. Absolutely.
Do amalgam fillings carry the same risk? No.

The dose makes the poison. Be aware, not afraid.

Does this foam carry potential risks, especially in certain circumstances? Absolutely, yes.

Does that mean all the machines are guaranteed to give you cancer?
Of course not. And without knowing precisely WHAT gases and how much is released, in what circumstances, there's no way to know that risk. But considering this foam has been in use for years and we haven't seen a dramatic surge of CPAP and BIPAP patients with these issues, the risk is probably small, especially if you don't use an ozone cleaner and have a new machine.

Does that mean that ALL foam is bad, no matter what machine, what kind of foam, and where it's placed in the system?
Absolutely not. Different foams are different compounds, different manufacturing processes, different components. You simply can't assume that ALL are a problem.

Does removing the foam automatically make it safer?
Definitely not. Aside from potentially damaging the machine and the risks of untreated/mistreated disordered breathing, by cutting out foam you are going to release far more particles and foreign debris, not to mention dust, glues and other substances with unknown health risks. That goes double for doing so on a machine that is not affected by the recall and therefore isn't even likely to have any risk. And that's the point. Nobody knows what the relative risks are and acting prematurely could simply be an expensive, unnecessary, and potentially more risky choice.

[racprops]

I am fully aware of all the things not good, even prescription drugs come with pages of possible side effects.

Nearly everything in your home can be harmful.

The Modern home has more chemicals in it that the best lab in 1905.

With almost everything it is a combination of how toxic a thing is VS expose time VS where and how your exposed to it.

They rate lots of stuff in parts per million.

Splash something on your hand is often no problem as our hands are harden, splash it on your arm more harm, space it on say your belly even more harm as we are more tender there. Now how long can something be on us, again the greater the harm.

NOW Splash it into your eyes and you can really be in trouble and again how long it takes to remove it is also very important which why some dangerous places where you likely to be around such bad stuff they will have eye washing stations and require the wearing of eye protection.

Same with many kinds of gasses, painting requites respirators and some hazmat suits...

SO a fast rule of thump is major parts of the human body is softer and needs better protection.

Like anything inside our skin.

Our lungs and other parts of our insides need the best protection possible.

We could be breathing in harmful gasses, harmful particles, and ingesting both.

FOR SEVEN TO EIGHT hours each and every night. THAT is both a exposure of a long time, apox. 1/3 of our day, seven days a week into a delicate inside of our bodies of a dangerous now known harmful product.

And for me for about 5 years.

There is nothing I do 7 to 8 hours long any day that exposes to me anything other that the air around me and all the elctriomanicatic radio and TV and so forth waves that runs thought us 24/7.

I am taking this very serious. I will not allow that amount of risk to happen to me IF I CAN DO ANYTHING ABOUT IT.

And I use power tools, drive a car on the freeways fast, I paint, make silicone molds, cast polyurethane plastic, cast fine pewter at 650 degrees, but not 7 to 8 hours 7 days a week, AND I use the correct safety equipment correctly and know the risks.

This was a hidden risk, a betrayal of my trust in Phillips.

Rich

---

From Phillips them selves:

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?
The recall notification (U.S. only) / field safety notice (International Markets) 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 post-market 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:
o Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.
• 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.

[Jadazu]

Does removing the foam automatically make it safer?
Definitely not. Aside from potentially damaging the machine and the risks of untreated/mistreated disordered breathing, by cutting out foam you are going to release far more particles and foreign debris, not to mention dust, glues and other substances with unknown health risks. That goes double for doing so on a machine that is not affected by the recall and therefore isn't even likely to have any risk. And that's the point. Nobody knows what the relative risks are and acting prematurely could simply be an expensive, unnecessary, and potentially more risky choice.

Exactly correct!

Using a rotary tool to do abrasive cutting of the plastic in the air path of the xPAP machine introduces minute plastic particles into the air path of the machine. Ditto for introducing the chemicals from glue and adhesive, products that are not food or medical grade, with unknown toxicity...

[racprops]

OH GOOD GOD...

I am a model builder along with all the other skills, I removed the housing and used air gun at 100PSI to blow all and any particles and dust out.

"Aside from potentially damaging the machine and the risks of untreated/mistreated disordered breathing, by cutting out foam you are going to release far more particles and foreign debris, not to mention dust, glues and other substances with unknown health risks. That goes double for doing so on a machine that is not affected by the recall and therefore isn't even likely to have any risk. And that's the point. Nobody knows what the relative risks are and acting prematurely could simply be an expensive, unnecessary, and potentially more risky choice."

I am getting very tired of all this arm chair quarter backing: I studied the way the foam was used, it is NOT a filter, as it seems the foam inside the Resmed fan housing seems to be. Which I pointed out that I considered a bigger risk of problems with the ResMed machine because of this.

With the Dreamstation A) it IS on the effected machine list. B) I careful considered how the foam is NOT directly in the air path and is NOT a filter so it is like putting sound proofing on your ceiling a helper ONLY.

I then considered the amount of exposure to the SO VERY SMALL amount of tape VS the very large amount of foam and made my chose to remove it.

So IF your a Phillips Dreamstation user:

So what have you done?? Risking it using the machines with known dangerous foam in them??

Bought filters for in line filtering that may throw off the machines reporting and operations??

Stop using your machines and risk the harm of not using them?

Bought a Resmed machine?

Stuck your head in the sand?

I sleep great with a lot less worry, how are you doing??

Rich

PS after three nights with a ResMed Air Curve 10 ASV, I am returning it for a refund. First as I am not allow to remove its foam within its fan because I will void any and all of the 6 months warranty, and refund and TWO as I LIKE the Phillips Dreamstation a LOT more for a lot of reasons.

I rather sleep with my cleaned out Dreamstation than with a Resmed with it unknown risk of its foam in its fan which appears to BE A FILTER with 100% of its air flow forced though it. NOTE THIS I believe as I do not have a ResMed fan assembly to test and check over so I am going by the video of one taken apart. I COULD be wrong about the foam in the fan, but I am not willing to risk it. OK??

OLD Saying: Fool me once shame on you...Fool me twice, shame on ME!!

[Ratchick]

And as an adult of presumably sound mind, you're entitled to act in any way you see fit. However by posting your assumptions as facts, that shifts it away from your own personal responsibility and to a point where other people could be damaged or endangered in the process, not to mention risking ruining an expensive piece of necessary medical equipment.

You do you, absolutely - but please, don't try to pretend you KNOW how the ResMed works personally, what the foam in a ResMed is, or that you have ANY definitive proof that your process is better/safer/less risky than the alternatives. You don't. None of us does. This is what makes you comfortable. We understand that. But that doesn't mean that people who feel differently can't express their views too.

People disagreeing with the principle of hacking the foam out of their machine aren't attacking you personally.

But I've added my 2 cents to the situation - take it or leave it, entirely up to you. No skin off my nose.

[SarcasticDave94]

Everyone that has a Respironics should solve the issue how they see fit for themself. Racprops has the freedom to do what he did for his reasoning. And you each can handle it your own way as well.

I have not had a Respironics ScreamStation since the 2017 major fiasco of a ScreamStation Auto BPAP for a heavy Central events status but Dopey Doc issued it for Obstructive events because they count as more serious...to Dopey Doc, ya know the one that had to retire after tangling with me.

I had seen and predicted ScreamStation issues in my future. So I fixed it my way. I demand ResMed.

Bye bye...

[racprops]

I have from the beginning warned that no one should do what I have done.

I have from the beginning said this will void any and all warranty's.

I have always said I do not know all.

I do not know what the foam is inside the ResMed fan housing.

I have said that I do not know of what IF any risks there may be from the foam inside the ResMed fan housing.

I have clearly stated that I alone do not trust ResMed statement of the safety of this foam.

I think I have clearly stated these are my opinions.

I do not see what else I can do.

Rich