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

[BobbieM]

I don’t know if this helps but I just received notification from my vendor on the Dreamstation recall: Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. 

It included a note from the manufacturer that says: Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s the air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.

These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment. 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. The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of these issues.

Details of machines affected and what to do next are listed in this link. 

https://www.apneaboard.com/PR-Recall.pdf

[SuperSleeper]

So I opened my 960 and it was just as he said so I removed any concern by removing it.

Rich

Rich, any chance you could post detailed instructions on exactly how you took the machine apart and removed the foam?  Sure would be nice if we had pictures of it, too, it that is possible.

EDIT:  I know you posted this video (below), and the guy shows the motor housing after it was removed from the machine, but it doesn't show how he removed it.







https://www.youtube.com/watch?app=desktop&v=NAXkLJ_v9F0

[SuperSleeper]

Hi folks, in order to comply with forum rule against posting links that lead to commercial DME websites, I've uploaded the PR Recall PDF file to our server so that folks won't have to break the rules, and I've edited the links above to the new link (below).

Please use this new link from now on for the Recall Instruction PDF:

https://www.apneaboard.com/PR-Recall.pdf

[WakeUpTime]

It's interesting that Sleeprider started this thread on May 23rd. It's another reminder to stay connected to ApneaBoard for the latest PAP news.

Just yesterday and today (June 15th), this is suddenly being widely reported in the main media. I just heard it reported in the radio news.

"Philips recalls sleep apnea machines, ventilators over cancer risk"

[racprops]

I have been ask about how to do these modifications:

You should NOT do this!! But here are the details for FYI only.

OK Here is a utube video on how to do this with the Phillips System One systems:

https://www.youtube.com/watch?v=bsFKk-tzFug&t=0s

All you need do is take out foam in the bottom of the unit.

And then put it back together.

And here is a video on the Dreamstation systems.

https://www.youtube.com/watch?v=TPX-SDSUW7E

At around 8 minutes you can see the problem, the fan housing with its SEALED in Black foam.

Here you totally will void any warnetee:

The ONLY way to remove the foam is to CUT into the shell and then to pull it out.

I being a model maker did this with a Dremal power tool.

This can be dangerous. IF you not a normal dremal user please do not do this.

I cut a "U" Shaped cut,about 3/4s of an inch wide and about 1 inch long following the foam behind the wall.

I did the on the side wall.

Then I bent the flap open and plucked the foam out using a pair of Hemostats.

I then bent the flap back into place leaving a very thin cut slot and resealed it with duct tape.

I then put it all back together.

WARNING: I cannot say how well these machines respond to this surgery.

So far I have done this to two Dreamstations. A BiPap machine and a ASV.

The BiPap seems to work, but I only sleep for under 4 hours with it.

I seemed to have a event under it and got a AHI of 5.23 that lasted for about 0:16;07 and the at this point the AHI was reported at 44.67 this did not seem good.

The rest of my sleep of 3:26:28 was other wise great or of 2:37:52 had a AHI rating of 1.14.

So either I had a problem that needed a ASV machine or the BiPap may not be working correctly.

All other reports by OSCAR of the night seemed normal.

I feel very lucky as at this point I have a possible good Bipap, and a good System One ASV 960, and I have ordered a Resmed Aircurve 10 ASV, so knowing I only need survive until it gets here, I took apart the Dreamstation ASV and did the same surgery on its motor housing.

Now here again I am concerned with its performance:

It took a couple of restarts to seem to settle down. Air flow seems slightly stronger. Other wise after this startup and running everything seems normal.

With my normal 4 to 5 hours of sleep (I sleep in such cycles normally) I just woke up, hit the bathroom, and refilled the water tank of the humidifier and read the SD Card in OSCAR:

SO in 4:43:15 I just got a reading of 0.0!! ALL reading are 0.0 BUT for Vibratory Snore (VS2) which shows 5.08.

Seems almost too good to be true, BUT my readings before the surgery HAS been very good, on the 13th I read a 0.25 out of 8:05:01 sleep of Hypopnea ONLY and on the 12th. I got a reading of 0.12 out of 8:08:47 of Hypopnea ONLY so both the slight improvement in air flow COULD cause this slight improvement of my readings and how tired I am last night could explain these great reading.

OR the machine is not able to read correctly..I do not know.

Again all of the other readings seem normal. I have readings of Vibratory Snore and Vibratory Snore (VS2) all the time so that is normal for me.

I need help on how to post pictures to show you these readings and other information.

This was drastic action.

I cannot suggest anyone do this.

Like Phillips, I say do this at your own risk.

This might make your machine malfunction.

All most surely Phillips will not cover your machine if you do this to any Dreamstation.

I am going back to bed and will report my morning readings when I get up.

One good thing about opening your machines will be you can check the fan and ITS air out let for any black powder and see IF your machine is having any problem with the foam at this point.

Sadly there is no test of any out gassing from the foam.

ALL things out gas: IF you can smell it, be it wood, or plastic any smell IS out gassing.

Good luck everyone.

Your in my prayers tonight.

Rich

[MikeBob]

Correct me if I am wrong. But doesn't the squirrel cage turbine get its intake air DIRECTLY through the sealed Polyurethane foam? I am simply using  the youtube videos as a reference.

[KSMatthew]

Correct me if I am wrong. But doesn't the squirrel cage turbine get its intake air DIRECTLY through the sealed Polyurethane foam? I am simply using  the youtube videos as a reference.

This is what I don't understand:

The air circuit should be:  Through the filter, into the fan chamber, out of the fan chamber, into the hose.

The foam "looks" like it is in a sealed area around the fan chamber.  I don't know how foam crumbs could get from the foam chamber into the fan chamber unless there really isn't a good seal between the two.  Maybe someone that's taken theirs apart can explain it better or add some pix.

The decomposition gasses from that foam might be able to work their way around until they find a way into the fan chamber.  But that also implies there isn't a seal between the foam chamber and the fan chamber.  OR, the gasses can escape from the foam chamber to the outside world and then get sucked through the filter.

[SuperSleeper]

Thanks Rich. If you want to email me your pictures of this procedure, I could then post them here if you’re still having trouble doing that. My email address is apneaboard@gmail.com

[RayBee]

Does anybody have any experience with the internals of the fan itself? It looks like it's all black plastic, but I'm curious if there are any foam vibration damping strips adhered to the insides that may also be a problem.

A dear friend of ours has a 4-1/2 year old Dreamstation CPAP. And she has been using a SoClean for years. I directed her to this thread so she can get the most up-to-date information on the problem. She has told me that she used her Dreamstation on and off for quite a while. She uses it for about two weeks and gets crushing headaches and upper respiratory infections. The doc gives her antibiotics and after a week or two the symptoms go away where she can start to use her Dreamstation again. And the cycle repeats without fail.

Also, her allergies have gotten much worse through the past several years. So much so, that her allergy docs have tested her and concocted a special recipe of injections to try to counter her allergies. I'm thinking that she really does suffer from allergies but the Dreamstation is exacerbating the situation.

I advised her to stop using her Dreamstation and retire the SoClean. And I gave her info and links on the Resmed Airsense 10 Autoset for Her. She has an appointment with her sleep doc and will be pushing for the Autoset for Her model. I think she does have insurance that covers the cost of her CPAP machine and consumables.

It sounds like there are folks like our dear friend who are experiencing the perfect storm and horrible reactions by using the Dreamstation with Ozone-generating machines. And there are others who don't have this combination of machine age with long-term ozone usage, high heat and high humidity. I think our friend definitely needs to stop using her machine, and others are probably ok to continue for now based on risk of the combination of things known to cause the problem. I just hope our friend won't have a long wait time for a replacement by the time she get in to see her sleep doc.

BTW... Great thread.

[JonathanLennox]

I have a Dreamstation as my current CPAP, so my current plan is to go back to my previous CPAP -- a REMstar SE from 2014.

However, since the REMstar SE is also a Philips product, I'm a little worried. The REMstar SE itself isn't listed on the recall list, but the REMstar SE Auto is.

Does anyone know if the REMstar SE and the REMstar SE Auto actually used a different foam, or is it just that this product hasn't been sold in long enough that Philips is using their "you should replace your CPAP every five years" to avoid recalling older CPAP models?

EDIT: Never mind, I see the REMstar SE explicitly listed in the "models not affected." Phew!