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

[racprops]

I give cardboard some thought BUT it can decompose, and if wet support or even encourage mold, even black mold.

So cardboard is out...

It can be a nightmare figuring out what is a safe product to use.

Rich

[MikeE3]

It can be a nightmare figuring out what is a safe product to use.
Rich

What about organic cotton? Could that possibly be used in the chamber to insulate the noise? If so, I suppose the next question would be how tight to pack it in the enclosure. Regular cotton may contain chemical residues, that's why I asked about using 'organic' cotton.

[racprops]

"What about organic cotton? "

From what I see it is dense enough to act more like a seal/gasket than a filter...cotton I feel is too porous for the use.

Rich

[RayBee]

Not having seen the System One internals other than what has been posted here. I can envision what may be a simple solution.

Buy a nonstick food-safe silicone sheet for $10 on Amazon. Cut it out to fit the footprint of the seal you need and use the existing (bad) foam (if still resilient enough) to compress it against the plastic housing where it needs to make the seal.

Or a different foam of any kind could be cut to fit to make the silicone sheet seal properly.

[hegel]

I would have thought recent developments in this thread would tend to suggest that ad hoc machine hacks to solve the foam issue actually result in, one, failure; and two, introduce new issues of their own.

I don't have one of the affected machines. If I did, I wouldn't be following the hack advice issued here. People are throwing out untried and untested ideas and using themselves as guinea pigs while suggesting others follow them down the road.

Warning!!! Warning!! No one here has designed a cpap machine or really knows how all the parts interrelate. Who knows if they're even functioning effectively after the hacks?

[Dog Slobber]

I would have thought recent developments in this thread would tend to suggest that ad hoc machine hacks to solve the foam issue actually result in, one, failure; and two, introduce new issues of their own.

or three, a perfectly acceptable night of treatment. Perhaps not as optimized as an unaltered device, but judging by the majority of comments I've seen therapy that is doing the job.

Many who are altering their device have few options.

[btreger]

Warning!!! Warning!! No one here has designed a cpap machine or really knows how all the parts interrelate. Who knows if they're even functioning effectively after the hacks?

I would certainly agree with this post. I cannot imagine making those types of modifications and risking my own health even more. 

But as numerous Board members have previously posted, everyone has the right to make their own decisions.

SoClean

We have not talked about this product for a while, which is fine with me.

But for the heck of it, I just went to their website and found this.

 They have not stoped or recalled their CPAP cleaner, in fact, they have been doing so well, they have been expanding their product line for more home use. 

SoClean O₃ Smarthome Cleaning System™
3-Stage Air Purifier™
O₃ Self-Cleaning Humidifier™


I guess the FDA is just letting these products alone, and will only take action after severe health conditions are reported.

[racprops]

I believe I have been able to understand these machines better than most.

One) I figured out once you cut into it to remove the foam which is NOT a filter and the airflow goes right past it it can be removed with no harm or system change. And that you must close the flaps and reseal the housing.

Two) I then tested it to see if there was any performance changes, and I found no changes to my sleep reports, BUT I was also able to compare the Dreamstation to a Resmed ASV as well, and got the same reports.

Three) I also posted a warning that I and others missed out on how the foam was used in the older System Ones.

Four) I think RayBee has a great idea: "Buy a nonstick food-safe silicone sheet for $10 on Amazon. Cut it out to fit the footprint of the seal you need and use the existing (bad) foam (if still resilient enough) to compress it against the plastic housing where it needs to make the seal."

As a food-grade product, I think that is both a safe idea and a good answer to how to put the older system back online and allow some desperate people some relief and not hack their Dreamstation in the hope of a repair or replacement that might be denied due to unauthorized changes made to the machines.

Now for the cherry on top a food-grade 3/8 foam replacement that we can feel will not degrade. Just to 100% remove that ofending foam.

Rich

[hegel]

Well, Rich has had to issue his own warning and recall of several hacked machines that he declared safe, until days later when he realized they still had foam in them.

It's what one doesn't know that kills ya. the old "unknown unknowns".

To me, the headline in this thread occurred several pages back and hasn't been commented on. The British medical device regulatory agency performed tests on PR machines with foam and published the following:

Biological safety risk assessment (based on the currently available data)

The available evidence suggests:
Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
Levels of diethylene glycol detected were within an acceptable margin of safety.
The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.
Laboratory analysis found that as the foam degraded it tended to stick to nearby surfaces as well as itself. This reduces the risk of respirable particles entering the breathing circuit.
Degradation of the polyurethane foam can be accelerated by off-label use of ozone decontamination or use in environments with high humidity and temperature, neither of which apply in the UK.
Available evidence suggests that most degraded foam particles are too big to be inhaled.
Diisocyanate is associated with isocyanate-induced asthma in a very small number of patients. For sensitised patients even low concentrations can cause adverse effects.

the upshot of this and other reviews is that the Brits aren't issuing a recall yet.

I still wouldn't use a recalled machine and find it unconscionable that PR used this foam to begin with. But the report is a bit of good news.

[btreger]

In a short response to hegel;

This is from a large DME in the UK

[DME links removed]

DreamStation Auto CPAP Machine
by: Philips Respironics


Important notice: Philips has temporarily paused the distribution of the DreamStation range of machines in the UK. We do not currently have a date for when they will be available again.
In the meantime, we recommend considering the equivalent machine from ResMed, the AirSense 10 AutoSet.

SoClean 2 CPAP Sanitiser
by: SoClean


UK's lowest price on the leading CPAP sanitizer
SoClean kills 99.9% of CPAP germs and bacteria in your mask, hose, and reservoir with no disassembly, no water, and no chemicals. It's the safer, healthier way to breathe cleaner.

Sometimes real facts do matter.

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Moderator Action: DME Link Removed

To maintain our status as an educational organization, links to DME-owned or DME-operated websites and links to pages that sell prescription-required items are prohibited in forum posts.  This is stated in the Apnea Board Rules.

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