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

[SingingSam]

There is another paragraph in the new Philips document (the one created 8/2/21 according to the document properties) that extends what already has been disclosed.

"Bacteria filters do not provide protection from the chemical emissions resulting from
manufacturing or continued foam degradation. Furthermore, possible gas emission
of the degraded foam has not been fully characterized yet throughout the life of the CPAP/BiLevel device."

My understanding until now was that the off-gasses were identified, that they were emitted in significant amounts during the first 24 hours of use followed by trace amounts thereafter.

Now they've disclosed that they have not "fully characterized" the gas emissions that are possible throughout the life of the device. I read that to mean that they have not fully disclosed the information.

In the System One owner's manual the life of the device is not specified. In the DreamStation owner's manual the life of the device is specified as 5 years. Regardless, that is a long time to be inhaling unknown gasses in unknown amounts from a foam made from petrochemicals.

What are those other gasses that we have been inhaling for years? In what amounts? Philips apparently thinks that we don't need to know and that we as stakeholders don't have the right to know.

It is increasingly clear that possible particles smaller than 2.69 microns and ongoing undisclosed off-gasses in unknown amounts make hazardous the continued use of any System One or DreamStation with the foam inside. Bacteria filters are not enough. Covering the foam, as some System One users have done, is not enough.

Now we have a new pair of relatively safe options as we wait for Philips/FDA to act:
1. Stop using the device as Philips has specified. Find a replacement. This is the safest option.
2. Remove the foam, confirm proper operation with a manometer, and keep using the foamless device. This option is not risk free. I believe that sensor locations make the risk greater in the DreamStation than the System One. However, this concern is not based on hands-on  experience.

Bad former options are:
1. Keep using the device as is if that is what your sleep doctor recommends. Your sleep doctor doesn't have all the facts about the risk of continued use of the machine as is. Your guess about the foam risk is about as good as your sleep doctor's guess.
2. Add an anti-bacterial filter to a foam-infested device. The filter will not be effective against particles smaller than 3 microns. The filter will not be effective at all against off-gasses that we now know are an ongoing "feature" of the foam. In the new document Philips discourages the use of bacterial filters in no uncertain terms. Philips says that in addition to being ineffective the filter will degrade the performance of the device. You won't necessarily see the degradation of performance in reports because the filter affects sensor operation.

There are threads possibly linked below concerning the removal of foam from System One and Dreamstation. Before you do anything it will be best to read the relevant thread all the way through, keeping in mind that many of the posts occurred prior to the most recent documentation from Philips.

The focus of this thread is the recall itself. The information above points to the fact that waiting for Philips/FDA to act is not a risk free option. Each of us must think it through, recognize the risks, know one's personal limitations, and choose accordingly.

[btreger]

The focus of this thread is the recall itself. The information above points to the fact that waiting for Philips/FDA to act is not a risk free option. Each of us must think it through, recognize the risks, know one's personal limitations, and choose accordingly.

A very well-stated argument with the facts to back up your conclusions. If my memory is still somewhat intact, At the early start of this thread, one of the Board Members basically said the same thing but included wording that went something like this," Instead of letting all this get you so depressed, just throw out your Philips and get a new vendor machine".

[SingingSam]

"Instead of letting all this get you so depressed, just throw out your Philips and get a new vendor machine".

Exactly. Which is why I have an appt. with my sleep doctor who has already promised he will prescribe a replacement machine from a replacement vendor. I need to study the ResMed line before that appt.

To further reduce anxiety, after protecting yourself from the foam just walk away. Consider the possibility that lawsuits will more likely be a source of abundant concerns than a source of abundant compensation.

This again is a personal choice. Some will be happier to do precisely the opposite.

The most difficult but potentially rewarding path is forgiveness. I'm not there. I will have to disengage for a while before I can just let it go. Note that I'm not saying forgive and forget. No, forgive and remember. Because Philips' prior behavior is the best indicator of their future behavior.

[oldgreenhead]

Inspired by DaveCar (and a few other users), and emboldened by the fact that I now have a new ResMed Aircurve 10 ASV, Last night I disassembled my 4 1/2 year old DS ASV.  I am not recommending this action.   It felt drastic.  However, after reading what others have found, I wanted to know, and know now, what I have been breathing for the last several years during my nightly "therapy".  There is a very helpful video on Youtube titled "How to replace the motor in a Philips Respironics DreamStation CPAP".  the individual who made the video is replacing the blower motor.  However, the steps are identical and will reveal what is in the bottom of the chamber below your blower.  

My inspection revealed a very small amount of black dust (very fine particles) in the bottom of the chamber below the motor.  I took pictures, wiped up the dust with a piece of clean paper towel, and sealed it in a plastic bag.  I am not adding a copy of the photos, because the resolution required to analyze them is too great for the forum.

Once again, I am NO LONGER USING this machine.  This machine has never been touched by a service center, and the designated parts have only been washed in soap and water as specified by Philips.  Whatever I might have discovered in the airway below the blower is a result of machine use as specified by Philips.

Disassembly and reassembly was simple and straightforward.  The only tools required are a T10 driver, a small flat bladed screwdriver, and a pair of needle nosed plyers.  

The next steps are up to Philips.  I am waiting, just like everyone else.

[btreger]

For Singingsam

Just an FYI

ResMed 10 is very close to its end-of-life cycle

The ResMed 11 the next-generation system should reach the market in the next month or so

[mrmagloo]

Which is why I have an appt. with my sleep doctor who has already promised he will prescribe a replacement machine from a replacement vendor. I need to study the ResMed line before that appt.

FWIW, I was a life long (CPAP use) Respironics customer. I got my first Remstar Auto in 1999 and it never skipped a beat, and I used it for 40,000+ hours.  I was actually using it for a backup after I heard of the DS recall.  That reliability is what prompted me to go with Philips that obviously now owns Respironics.

However, even though the Remstar Auto's of this generation was not included in the recall, I did try to research it a bit, and in some YT disassembly videos, I could clearly see the use of a black foam - Probably not the same type, but a black foam nonetheless. As a matter of fact, the foam is molded in a manner where the foam itself is the air passage from the air filter to the motor.  So in an abundance of caution, I stopped using it and immediately bought an Resmed AS10.

That said, I will say that the change over to Resmed has far better than hoped.  I was concerned too.  While I was always able to keep my AHI with both of my Philips/Respironics machines below 5.0, I have been amazed how much better the AS10 is.  The difference in comfort was pretty amazing and it seems to follow my breath much, much better.  Clearly a considerably better algorithm, at least for me, and for the first time, I am actually seeing a couple of AHI's in the 1's.  Again, I never tried a different machine over the last 22 years, so this was quite revolutionary.

My only point is, I'm glad your Doctor is willing to prescribe a new machine.  I hope that if you do chose Resmed, that your transition is as smooth and beneficial as I experienced. I am not sure what this recall will eventually bring, but best case, the repaired/replaced DS will never be anything but a back up.  Good luck.

[oldgreenhead]

This post is an echo to mrmagloo on Resmed. I started using a CPAP in late 2009. My first machine was a Resmed. I was switched to a Philips ASV by a new Doc in 2017 after a relocation. The Philips ASV had a major impact on my AHI (from 10 to the low ones) because of emerging Central apnea. My move this summer back to Resmed because of the recall was an eyeopener! My average AHI (after just a few weeks) is now below one. I am sleeping better and more, also a good thing. Though the DME that put me in the PR had no way of knowing, obviously it became a bad choice over time. I am grateful to be back with Resmed.

[btreger]

The New York Times

Breathing Machine Recall Over Possible Cancer Risk Leaves Millions Scrambling for Substitutes

People with sleep apnea and other ailments who rely on CPAP and more than a dozen devices made by Philips are facing lengthy delays for replacements.

The F.D.A. is the sole regulator of these machines, but does not conduct hands-on inspections of the repair and replacement devices, said Shirley Simson, an agency spokeswoman. Beyond providing the agency with a plan, Philips must conduct extensive testing and the F.D.A. will then review the data before any machines can be sent to patients.

“We will authorize such a plan as soon as the company provides the agency with sufficient evidence to support the safe and effective mitigation of the product defect, including fixing or replacing the devices patients are currently using,” she said.

CPAP Recall Over Potential Cancer Risks Leaves Millions Scrambling - The New York Times (nytimes.com)

[DaveCar]

"Last night I disassembled my 4 1/2 year old DS ASV"

You found the black dust/bits.  That means you also inhaled similar sizes and small, in addition to the VOCs. 
Two questions then:
Did you use SoClean or some other type of ozone exposure ?
What type of humidity was your machine exposed to ?  

[WakeUpTime]

<< ABOVE NEWS ARTICLE >>  Leaves Millions Scrambling

Your post of today's NY TIMES article is the best so far at describing the current state of events, and the impact on end-users.  Philips is going to be further off all its time and repair estimates.  Philips was expecting the FDA approvals by now.  The article seems to suggest that the FDA isn't close to approving Philips' 200+ applications. 

"The company has to submit a repair-and-replacement program for the flawed components to the F.D.A.  In the meantime,
there are shortages and backlogged orders, created by delays in the replacements
and the use of similar devices in emergency rooms and intensive-care units during the coronavirus pandemic."

Strangely, no one seems to be making the connection that, when Philips talks about "notifying customers", they don't mean end-users.  Almost all the end-users in all these news reports discovered the recall by accident through unconventional means.

"The company, he said, was “already producing repair kits and replacement devices in large quantities”

of about 55,000 units a week that had not yet been cleared for shipping."

[Repair Kit Production] That estimate is very misleading and the reporter should have asked for clarification.  "Producing repair kits" does not imply that Philips is fixing devices at the rate of 55,000/week.  One technician may only be able to repair 3-4 devices every hour.  They're going to need a large number of technicians to repair 2M+ devices that aren't being replaced.

At that rate, it would take Philips 72 weeks then to replace/replace 4M units worldwide.  If Philips does reach its goal of 80,000/week at the end of the year, then it may be faster.  However, many external factors are against them:  awaiting FDA approvals, setting up country repair facilities with fully trained technicians, "supply chain challenges", delivery schedules to bring in and ship out units, etc.

Lastly, if I were the FDA, I'd be furious at Philips for producing significant quantities of the repair kits currently, before receiving the official FDA approvals.  What if the FDA rejects Philips' replacement foam?  Philips has put all the pressure on the FDA, perhaps hoping that some of the frustration (and blame) will shift to them.  The FDA may push back.