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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
btreger: concerning what may happen to your health:

--preliminary tests in Britain by the medical device regulatory agency (and others here?) suggest that foam off gassing was only liable to occur in the first 24 hours of a machine's operation
--not all foam degrades in all machines
--have you noticed black specks in your mask or water tub? the guy from Supplier #1 said that they had only heard one complaint about this over the years. that would be an indicator of foam degrading in your machine

It may turn out that the health hazards are minimal or even non existent for the majority of users.  preliminary info suggests that the risks are very small. Recall that the British agency is an independent body that ran their own tests.  One would assume that tests were run on the foam by PR at least prior to the release of the affected machines. One would think that they had to meet certain standards for safety. this would be standard procedure for people making medical devices.

I say this to suggest that anxiety may not be warranted at all. If new, worse info emerges, people can start worrying then, I suppose. and then inform their doctors to be on the lookout for any issues.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I have found this thread very helpful.  I have been on CPAP for 25 years and have been through a bunch of different machines over the years..  I get my treatment through the VA now and have found them to be practically useless for any kind of treatment other than sending out masks and filters. It took them two months to even send out a notice about this recall. So I just found out this week.

For the past year and a half, I have been having respiratory issues with symptoms much like those described in the recall warnings. No one has been able to diagnose or help.  It is true that with sleep apnea, you really must take a lot of the responsibility for your care, like knowing how to set your machine and pressures, and getting your own equipment.  Unfortunately, the VA will NOT provide a prescription for equipment so I have had to take alternative measures.  

At any rate, I am trying to get a new machine from the VA but in the meantime I have pulled the foam from my DreamStation and am hoping it will provide some relief from the breathing problems I have been experiencing. Although the machine is noisier, throwing a towel over it provides the same results as polyurethanve foam in the airway. Can''t believe that was even an option.  So Fingers are crossed I'll feel better and get a new machine soon.

This forum has been very helpful over the years. I have appreciated being able to get clinical manuals and the software to read the data from my machine.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
ADMIN NOTE:

This thread will remain in the Main Forum for now, due to the importance of the issue at hand and the fact that it's directly related to sleep apnea and CPAP.

That said, I would ask our members to try their best to remain on-topic and not get too far off the subject matter (ie- the Recall issues).

Some of the staff and other members (understandably) have expressed their concern that some posts in the thread are spinning off into subject matter not directly related the recall.  I'd like us to do our best to address those concerns by trying hard not to go off on tangents.

There's a LOT of people around the world who are reading this thread, so it is frustrating to them when they come here for info about the recall and have to wade through several off-topic posts.

As to what's considered "off-topic", I ask you to police yourselves in that regard - since one person's "off-topic" post differs from another person's idea of off-topic.  Please think carefully prior to posting, in other words.  Ask yourself if the info you're going to post is necessary or important for others to read?  Also ask yourself if your post directly relates to the recall or not?

We're not going to outright censor anyone here from expressing opinions - but please make sure your opinion is relevant to the topic at hand, rather than using this thread as an outlet to bring up other non-related issues you may want to express.

Remember, you can always start a brand new thread for a topic not directly related to the PR Recall issue.

Thanks for your help on this.   Coffee
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Sorry, we did stray a little off subject, in my defence in my case this issue has made me consider the Other major maker of these machines, which to me is a very important concern.

Would you believe I came THIS close to spending $1300.00 to buy a ResMed machine when I discovered that they were NOT 100% foam free??

I personally found this fact very upsetting, there just seems no getting away from foam in the sleep machines.

I only had 10 days to make up my mind, stay with an already paid for Phillips machine that I removed the foam or spend $1300.00 and TRUST ANOTHER sleep machine maker to be telling the truth and that they REALLY know their foam is safe.

I would bet a million dollars if you were to ask Phillips say a year ago if their foam was safe that they would say YES it is safe.

So for many of us the big question is what to do??

Buy a different make of machine??

Keep the one we have?

Wait and pray Phillips latest news given to a service/DME as shown on utube is 100% true and accurate that most of us will not get cancer and that they will replace or repair our machines very soon??

I really do feel discussions of the caricature and behaviour of ResMed towards us is relevant to making a choice as to what we do. Thus my posts about this behaviour.

Rich
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Rich- Resmed is your white whale, we get it….you’ve made your point.

Now back to our on point topic.
Glen in Ft Lauderdale

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I'm in the same boat as others. I cannot find a Resmed locally that fits my prescription, which the doctor gave me almost 4 weeks ago.
My DME has told me that they are backlogged terribly, and are not at present issuing any Resmeds, because of so great demands.

So I've tried out of town at places all over - those who support medicare, and who have Resmeds, but I'm getting the same answer from everyone.
They tell me that the ball is in Philips court, and as of yesterday, they have not received any clear directives from Philips.
Most seem to think that Philips will: 1) send out filters to all affected machines 2) send machines to qualified repair shops for fixing the problem.

Here is a direct statement that is typical of the replies I've been getting, and this one came in on my email just a few moments ago.

"Unfortunately, we are all in the same boat. The 5-year rule will be in place anywhere you go, even with a dr's prescription. Respironics is working on the issue and the last I heard is by the end of this week they will have a plan. The way it sounds is they will send out remanufactured machines, but I am not for sure. "

I was told by my local DME that they would get me a new machine in January (when my 5 years end). Until then, they can do NOTHING.
Of course, since I stopped using my machine (as directed by Philips), I will not maintain my 4-hr minimum per night by then. So, since I've lost faith in any help from DMEs, I wonder if they will deny me a machine because of non-compliance. It wouldn't surprise me at all. (sorry)

This is awful!
Jay
PAP Mode: VPAP-S
EPAP 8.4 IPAP 10.6 
ave AHI = .5 (so far)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
packtheknife

Most Insurance will consider your machine "Paid" for in 13 Months of compliance.

I receive a notice of that with my machine and I am on Medicare.

If you have done 4 years it is very well a done deal.

At least I believe you can relax on that concern.

Rich
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
No Rich. Medicare Advantage HMO plans do NOT consider your machine paid for and yours after 13 months. Mine specifies quite emphatically that it is not mine... EVER, unlike regular Medicare.

And just to throw my experience out there... I have yet to have received ANY notice about the recall from ANYBODY. Not my doctor. Not my DME. Not Philips. My adult child sent me a text with a link to a tiny buried news feed article he just happened upon the evening of the day it was announced. I have still to have actually receive any "formal" notice from anyone. I'm the one who has initiated all contact with any of them.

My guess would be yes, they will find you out of compliance for non-use and deny a new device if you simply do not use the recalled device waiting for instructions and can not afford or find a replacement to purchase. They may relent and allow you to have another but probably only after a new sleep study which they will probably refuse to pay for. So noncompliant if you don't use it and noncompliant with Philips recall instructions if you do use it, regardless of any possible health issues either way.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Must we always assume the worst? Actually patients are being "compliant" if the DO stop using their machines. This isn't a situation that was foreseen and written into the rule books. Let's recall that there are good people working in health care and, yes, even in the health care industry. They aren't out just looking for ways to screw patients over.

That said, it's shameful that you haven't been alerted by your dme.

I'm really not an apologist for Phillips, but...they will need to contact, what, half a million people? and they don't have all those records by any means. Most don't buy their machines directly from Phillips. How would they have one's email or phone number?
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Recommendation:

This is meant for all current users of any of the recalled Philips products;

If you were a user and recently switched to a different product this for you too.

Print off a copy of the FDA recall statement from their web page.

Bring that printout to the office of your Primary Care Doctor, or email it.

Make sure that they understand that you want that to be included in your medical record.

The reason is simple if sometime in the future you started to exhibit specific symptoms the potential answer would already be in your medical records and could save your life.

If you don't have a Primary Care Doctor then give the document to a close family member.  
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