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

[SingingSam]

BHappy, I'm sorry you're in the same boat with us. Individually we are on our own. During this interim period an agreement has not yet emerged about the best method of coping with the problem. What is best for others is not necessarily best for you anyway.

The length of the interim period is unknown. The recall occurred in June. The best estimate is that 3 to 4 million machines are recalled. The timing is unknown but believed to be 9 to 12 months, and possibly longer.

Your machine has not been exposed to unauthorized cleaning. Therefore your greatest risk is the degradation of your foam by a chemical reaction called hydrolysis, in which molecules of water break down one or more of the foam's chemical bonds, resulting in particles as small as 2.69 microns. The smallest particles are the most dangerous because they are more likely to avoid the defenses inside the nasal cavities. What happens when these particles reach the lungs is unknown to us. The seriousness of the problem is hotly debated. According to Philips the majority of particles are larger than 8 microns. I take that to mean that about 49% of the particles are 8 microns or smaller.

Others on this board surely will disagree with my assessment of the distribution of particle sizes. You decide who is correct, the guy who gives you facts, or anyone who posts ad hominen attacks while complimenting the brilliant caring people at Philips and the FDA.

The water molecules come from humidity in the air. The speed of the reaction is related to two factors, the amount of humidity and the amount of heat inside your DreamStation. I have no data about how hot it gets inside a DreamStation. The interior temperature will vary with the ambient room temperature and how hard your machine must work to deliver your settings. The more air pressure is required, the harder the blower motor works, the warmer the blower motor gets, and the warmer the foam gets. The speed of the chemical reaction will roughly double with every 10°C (18°F) increase of foam temperature. The inside of the machine most likely will be hottest a few minutes after you've turned it off, when there is no more air flow to provide cooling.

There also is a risk of exposure to off-gas from the foam. This risk is greatest during the first 24 hours of operation of a new DreamStation. Then it rapidly declines. But it doesn't go away completely according to Philips. The gasses produced by the foam cannot be removed by an anti-bacterial filter.

I won't address your legal options. Your actions to defend your health could affect the merits of your legal case.

Your health-related options are, in no particular order:
1. Replace the machine with a ResMed equivalent or a DreamStation2. Replacement machines are scarce and expensive due to the recall.
2. Stop using the machine, without replacement. You or your sleep doctor will have to assess the risk of dropping xPAP therapy against the risk of continued exposure to particles and off-gasses. The latter risk is not clearly known. It is possible that some individuals are more sensitive than others to the particles and gasses.
3. The first option that isn't authorized by Philips is to keep using the machine as is until Philips provides an opportunity to replace the foam with something safer.
4. Related to option 3, modify the machine's environment while continuing to use the machine as is. Possibilities are to reduce the temperature and reduce the humidity. However, relative humidity below 40% is less healthy than humidity in the 40-60% range. If you travel with the machine, keep the machine away from hot places like car trunks. If that isn't possible then consider storing the DreamStation inside a cooler with "blue ice" to keep the DreamStation cool while avoiding moisture.
5. Add an anti-bacterial filter between the DreamStation and the hose. Philips considers this to be off-label use for recalled xPAP machines. The anti-bacterial filter will trap most but not all of the particles. Because of the recall, AB filters are scarce relative to demand and getting more expensive. If you use a filter then you'll probably have to stop using the humidifier. It is unknown how DreamStation settings are affected by an AB filter. The filter could affect pressure, air flow and the operation of the DreamStation's sensors. How frequently to change filters is something you'll have to decide by trial and error.
6. Remove the foam yourself, or pay someone to remove it. This unauthorized option should be studied very carefully before proceeding if you're inclined to try it. If you are sensitive to noise when you sleep, then do not worry. I've seen no reports that removing the foam causes an objectionable increase in either the volume or the pitch of the DreamStation's sound; the change of sound is generally reported to be very slight. There are various methods of foam removal. None of them are risk free. There's a thread in this forum dedicated to DreamStation foam removal. There are videos also online. Not everything you read or see will work well. 

I don't know what to make of the whirring sound that you reported. I have not see similar reports in the context of the recall, and I have read a lot. That doesn't mean the whirring is unrelated, but is seems unlikely to be related.

Consider carefully before deciding what actions to take. Don't let anyone tell you that you are not sovereign over your body and your machine. Good luck with whatever you decide.

[btreger]

In an earlier post, I said I contacted the AASM to ask if they kept information on the CPAP equipment used in their 2500 accredited sleep centers.

In their response, they stated that they do not collect data on the manufacturer of CPAP devices being utilized. 

Today I received another e-mail from them with this information: Note: This is not new information for most of us, but I thought it was extremely nice of them to share this and I asked if they could keep me updated on any new information. 

All guidance, including sample documents, are being posted to the AASM website- https://aasm.org/clinical-resources/guid...ap-devices. It also has a section on additional guidance available from other professional societies or government organizations in the FAQ section, which is updated as we get additional information.

 
The following statements are available:

• American Thoracic Society: Recommendations for Sleep and Critical Care Medicine Professionals Regarding Philips Recall Notice
  
• Australian Department of Health | Therapeutic Goods Administration: Philips recall action for CPAP, Bi-Level PAP devices, and mechanical ventilators
  
• Canadian Sleep Society: Phillips Respironics Positive Pressure Device Recall
  
• CHEST: What You Need to Know About the Philips PAP Device Recall (NEW 7/23/21)
  
• DME MACs: Frequently Asked Questions – Philips Respironics Respiratory Products Recall
  
• European Respiratory Society: Recommendations for respiratory, sleep, and critical care medical professionals and patients regarding the Philips recall notice
  
• U.S. Food and Drug Administration: FDA Safety Communication
  
• U.S. Food and Drug Administration: Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals (NEW 7/22/21)
  
• U.S. Food and Drug Administration: Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam (NEW 7/22/21)
  
• U.S. Food and Drug Administration: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions (NEW 7/29/21)
  
• Veterans Health Administration National Center for Patient Safety: Philips CPAP Recall
  

 
We also have a page dedicated to patients- Philips PAP device recall: Guidance for patients as well as an FAQ page related to the recall.   

[WakeUpTime]

I bought it brand new from supplier 2 and I have never exposed the machine to a commercial cleaner ... 

That's a very different confidence level then.  I had thought Supplier #2 only sold second-hand PAP devices, from the nature of their name.  The breakdown of the foam in your DreamStation would likely be more similar to what's being seen with other DreamStation more typical users, though machine age, usage, humidity and temperatures play a role too.

The post from SingingSam above described your situation and possible actions better than most anyone else could have.  I can't think of anything more to add to it.  It's a well researched credible experienced reply, from someone who has also been impacted by the Philips Recall.

Keep us updated on how things evolve.  You'll get some continued supportive comments from many others here.

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***Note:  We're trying to cut down on duplicating lengthy posts with the Reply-with-Quote button.  It makes it more difficult to read through many postings.  If we use "Reply with Quote", please only use as little as possible from the post you're replying to, such as a few words or a sentence.  Or if it's very clear what & who you're replying to (as in being the very next post for example), one could simply use the REPLY button.  

Perhaps one of the Moderators could edit out the lengthy duplication of info in Post #1,050.

[DaveCar]

Is it logical to assume that once Philips replaces a machine (with refurb or new), the hard evidence is gone ?
I have a two year old machine, so if I take it apart to inspect I kill the warranty. But if I let it go, I feel like " due to the number of devices involved in the recall, we are unable to discover foam exposure on an individual basis".

[WakeUpTime]

...discover foam exposure on an individual basis

You're absolutely right.  It seems certain than Philips would never analyze, photograph, or return the evidence of any decomposing foam to the device owner.  They would say it was "too costly" and would slow the process; though it's really against their "best interests" to do.  Not only would it be extremely valuable to the recalled device owner, the overall value of that compiled cumulative database would be extremely valuable to all device owners, health insurance companies, medical authorities and perhaps the entire industry.

So what are our options?

(1) Do nothing.  We'd be throwing away any proof of individual exposure, forever losing any connection between any future new health issues and our previous use of a recalled faulty-foam device.  Most might be comfortable doing that.  However, I believe we should not be thinking of the present but focused on the future.  How will we feel about that 3 years from now?  How would we feel about that 7 years from now, if we should develop a form of cancer that is related to one of the chemical components used in the faulty foam?

(2) Remove the foam before returning to a Philips service depot for a "fix"/replacement.  Yes, there are possible warranty issues for those with devices still under warranty.  However, DS1 users might expect to get a new DS2 replacement or another separate refurbished DS1 cross-shipped (rather than repairing your specific DS1).  Philips says they are stock-piling inventories right now of both DS2s and new DS1s that they've pulled back from dealers.  

It's also realistic to assume that, those still under warranty, would receive the balance of their warranty for a replacement device - or a completely new warranty.  Let's also keep in mind that this is no ordinary "warranty" service.  Philips will likely use a contracted 3rd party service company to assist with the refurbishing process.  I seriously doubt that 3rd party would be "on alert" for returned devices that had no foam, and notify Philips.  

Therefore, odds are that it's highly unlikely (personal opinion only) that removing/storing your current DS1 faulty foam, prior to returning your device for refurbishment/replacement, would be used against you in any way.  I'm going to wait until the day before return-shipping my system before removing/storing my faulty foam.  My plan might change, depending how the many related-events evolve.  

Each affected user should choose the option that they're most comfortable with.  Very few device owners, especially outside of ApneaBoard, would even consider opening up their main system; thereby forever losing a potentially valuable piece of evidence that would, at the very least, give them greater peace-of-mind.

I'm hoping that we get a third option:

(3) Get a directive from a medical authority, government agency, or a judge (within a class-action) to protect users' right-to-know.  It's extremely important that this is established BEFORE Philips asks us to return our devices.  We need to educate these influencers on why this is very important to recalled device users.

Doctors and insurance companies should support users' right-to-know.  For insurance companies, if some recalled device users should later develop issues related to their use of a Philips recalled device, those may not be "natural occurring outcomes" but caused/influenced by a faulty product.  For doctors, they would be alerted to looking for specific issues if they knew their patient used a recalled device that had foam which deteriorated from its original state.

This is a serious issue that only current (or past) owners of Philips' recalled devices would truly understand.

[btreger]

RE .>above<

This is only my opinion, I have no new facts to rely on;

I think Philips wants to get back the whole product, not one that has been altered or modified.

This is totally for self-preservation and keeps them in control of the narrative. They do want a user, or a user's lawyer submitting the foam to an outside lab for analysis.

I do not believe they will just ship a DreamStation 2 out to anyone until they receive the original.

If they receive a machine back that has been altered or modified they may decline to send back anything.

I can picture them deploying all kinds of legal roadblocks and red tape till the cows come home.

Way before we ever heard of the foam problem, Philips has been circling the wagons and looking at all the possible contingencies they have. They have already identified this scenario and taken the necessary steps to avoid any unnecessary publicity.

Just saying, hoping I am totally wrong. 


   

[WakeUpTime]

I'm trying to imagine this possible conversation:

[Philips]  "We're calling to inform you that your faulty foam is missing from your recalled system.  Our technician has stopped the refurbishment of your system.  We won't put a new replacement foam in your device.  Also, please return the faulty foam to us."

[Customer]  My foam has completely disintegrated?  Philips, could you please put your response in writing?  My lawyer, insurance company, doctor, etc., would be interested in knowing that the faulty foam has completely disintegrated from my system and been ingested by me.

Just speaking for myself only, I would look forward to that conversation with Philips.  After that conversation, before contacting a lengthy list of people, I'd provide the local news media station with all the details.  That would be an incredible move by Philips, who is continuing to be unfavorably viewed for its poor responsive actions to the recall.  

And then Philips, in this hypothetical scenario, would return my machine to me without being refurbished with new foam, along with a detailed letter.  If that rejection letter also accused me of removing the foam, or opening the machine, that would be a valuable letter, which I'd make sure gets national or world-wide attention by many parties.  And I'd still have my machine back with the faulty foam removed.

[oldgreenhead]

I won’t speculate on what specific future actions Philips may take with respect to this recall.  However, I completely agree that Philips  handling of this incident is a textbook example of what not to in a case of a medical device recall.  They have bungled this thing badly.  It’s not difficult for me to imagine that they may choose to exit this business entirely.  If I were planning the sale of this business, I would certainly act to stretch out the repair/replace timeline to minimize the number of ultimate claims.  I would try to make the repair/replace alternative as unpalatable as possible. 

I would take that entire loss, once quantified, as “discontinued operations”, and sell the operating division as a going concern.  I am certain there are buyers out there.  Losses taken as discontinued operations have little or no impact on future stock prices.  Any class action lawsuits can be buried in there too.  Keep in mind that even class action plaintiffs must demonstrate harm.  I may be angry about this whole mess as a user; however, I can’t really demonstrate much harm.  My direct expenses barely have three zeros.  Further, I chose not to wait for Philips to solve the problem.  That in itself makes me responsible, in part, for my own damages.

[btreger]

That would be an incredible move by Philips, who is continuing to be unfavorably viewed for its poor responsive actions to the recall. 

That is exactly the real problem we are facing. We all have expressed our own views of Philips. There have been a handful of articles we have uncovered that express the same views we have.

Even the fact that Philips has gone for 12 years selling poisonous and deadly health products, for the most part, that news has been muted and kept at a level that most of the world has no interest in.

We are stuck in the mud, kind of like being in our own bubble. That would include Facebook and Youtube videos.

WakeUpTime tried to bring this story to 60 Minutes. I followed his efforts by going to the, (AMA, New York Times, and Washington Post).
I followed that up by also going to 60 Minutes, and asking the AASM to do the same. 

I guess I am totally frustrated being in the same position we were in on June 14, with everyone just waiting on Philips.

[hegel]

of course...it's also possible that the issue is fairly minor. And that's why 60 minutes and all the rest aren't screaming to Heaven. There's not that much of an issue. Which would be good news for sure.

Frankly, since the simplest explanation is almost always the correct one,--Occam's Razor--this last is most probable. Recall that this HAS been covered in the media. Claiming that "the news has been muted and kept at a level...et." (Muted by who? worldwide? How could that even be accomplished?) is a bit far fetched. Again, it's more likely the simpler explanation is correct. We should all hope so.