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

[Sleeprider]

I think this thread has served its purpose to inform members of the advisory and recall. The opinions currently being debated are really not helping anyone to make a derision of what to do with their recalled machines. You know the facts, and until Philips Respironics provides further guidance, all the speculation on repair or other options is just not helpful. Please consider confining your posts in this thread to the actual exchange or warranty process. Philips is in the driver's seat on this, and has also encrypted the data on new DS-2 machines. In my opinion, a DS 2 simply gives you a brick. From now on, you will pay your doctor for your CPAP data. If that is what you want, go get it. If you don't think that is right, get a Resmed as a replacement.

[buddy0329]

I think this thread has served its purpose to inform members of the advisory and recall. The opinions currently being debated are really not helping anyone to make a derision of what to do with their recalled machines.  You know the facts, and until Philips Respironics provides further guidance, all the speculation on repair or other options is just not helpful.  Please consider confining your posts in this thread to the actual exchange or warranty process.  Philips is in the driver's seat on this, and has also encrypted the data on new DS-2 machines.  In my opinion, a DS 2 simply gives you a brick.  From now on, you will pay your doctor for your CPAP data.  If that is what you want, go get it.  If you don't think that is right, get a Resmed as a replacement.

Sleeprider,

Is there a sense that the encryption you reference above is an insurmountable obstacle for the development team?

Did the Sleepyhead developers run into similar circumstances when the last generation of machines were released?  I'm wondering how much of a risk this may be not just with Philips but also with Resmed when they release their new Airsense 11 eventually.

I find myself debating every night whether I should order an Autoset 10 or just wait a few more weeks for the Resmed 11 announcement & release.

[WakeUpTime]

I also pray we do not find a Ford Gate here. Where a memo from inside Ford showed they decided it was cost effective to take the losses from law suits that SPEND THE MONEY to fix the cars.

Consider that is seems Phillips may have known of this problem three OR more years ago.

History shows that European corporations are significantly better at keep a tight ship internally.  The most recent example is VW's diesel-gate, where it took a U.S. VW Executive to blow the whistle on the continually covered up cheating and false advertising.  European employees usually tend to remain at companies much longer, so they typically don't want to jeopardize a good long-term career.  They aren't as easily lured away for a few dollars more.  From my experience, large European companies can also do a much better job of locking in employee behaviors contractually.  

European regulators tend to go easier on European companies too.  If any internal Philips memos exist, there will need to be someone in the design, production, quality assurance, etc., that'll need to leak a memo.  Any of the pending U.S. lawsuits should start with soliciting documentation related to the complete re-engineering of the DreamStation 2 - Philips first new system in a very long time that finally stopped using the flawed disintegrating foam in the system air chamber. 

There is one thing against finding out how much, and how long, Philips knew about the issues related to the recall:  Philips has had a very long time to prepare for their carefully planned device recall.  They first leaked the news (likely intentionally to prepare investors) in the early part of the year.  They therefore were planning the rollout of information (and the fix) well before that.  Philips had ample time to remove any sensitive documents from their systems, or reword, or reclassify them.  They likely have had ample time to discuss the issue with "very important employees".

The European PAP user community needs to get upset about this and the European media needs to more widely publicize the recall and users' reactions.

Many European (and Asian) countries have more socialized medical systems.  Perhaps many Europeans are directly compensated for their PAP purchases, so they're not taking the recall as personal.  I'm pretty sure those country medical departments, who bulk purchase significant quantities of PAP machines, will demand immediate fixes, compensations or replacements from Philips, if they are to remain an ongoing system provider to that country medical provider.

It wouldn't take much of an investment to investigate a variety of different Philips recalled systems for deteriorating foam particles.  Whoever it is could purchase new Philips replacement parts from distributors to compare to older systems - though Philips will unlikely now sell any older system parts that may contain the defective foam.  They could flush them with SoClean continually for several days to approximate typical use over several years.  The results could be powerful and there may be groups that would pay significantly for those results.

Whichever U.S. law firm ends up with the largest case, they need to coordinate with a good European law firm near Philips' backyard, who will then work locally to find the right sources internally.


It's so ironic that the medical device that's temporarily curing us of an ailment (sleep apnea) could be afflicting us over time with a more severe life-threatening ailment (cancer, etc.) - and in such a gradual way that would never point the figure at the root cause (deteriorating foam containing a proven cancer-causing chemical).  Philips recalled device users, at least in the U.S., will ultimately demand to know to what degree their use of their recalled Philips medical device contributed towards any current (or future) medical condition.

[Sleeprider]

Buddy, I don't know if the encryption is insurmountable, but it sure does represent a challenge.  Philips official position is
"Philips has determined that as a company we must encrypt data for privacy and security reasons. When writing a prescription file to an SD Card using Care Orchestrator, such a file will be created for a specific target device that can decrypt the prescription and other files that were created by Care Orchestrator "

This statement means they intend to deny patients access to detailed data.  The data may have keys that are specific to the machine serial number or have another decryption algorithm.  So far, we cannot support Philips Respironics machines in Oscar until that problem is solved. It would be nice to think we could call on Philips for help on this, but considering their obvious efforts to prevent patients from seeing their own data, and making them rely in a DME or physician, I'll let you calculate the odds.  Oscar is a non-profit, volunteer effort to enable patients to access their data.  Philips is setting an encryption on new machines to prevent this.  How much effort would  you suggest the volunteers expend to help Philips ?  People that want data without paying doctor fees or other access, will probably look elsewhere, and should.

[WakeUpTime]

^ ...in the name of privacy and security ...

That phrase has been used so widely by companies to go far beyond protecting the privacy and security of end-users.  Philips is obviously using that phrase to lock out third party developers and accessory product providers.  

Future PAP buyers therefore need to become aware of this limitation with recent Philips systems.  Say 'no' to closed systems.

[kappa]

And as much as I hate to point this out but Resmed may not face the level of legal trouble as does Phillips does here within the US as they are based in Australia.  

Fact check please. (quoting Wikipedia) ResMed is a San Diego, California based medical equipment company which operates in more than 140 countries worldwide and has manufacturing facilities in Australia, Singapore, France, and the United States. It was established in 1989 in Australia. It relocated to San Diego in 1990. 

Respironics is an American subsidiary of a Philips, a Dutch conglomerate. The primary Philips announcements have a byline of "Amsterdam, the Netherlands".

While we Aussies love to claim ownership of anything with a fleeting association with the land down under I don't think that's significant here. And even if they were still based here it wouldn't make any real difference from a legal perspective (although IANAL).

Regarding AirSense11 support with OSCAR I expect this will not be an issue. Phil is working on this. I was able to do a basic import of mrfast's data without any OSCAR changes by creating an Identification.tgt file based on the json file that replaces it, and was able to see full flow and pressure data, events, etc, but settings format has changed slightly.

[buddy0329]

Buddy, I don't know if the encryption is insurmountable, but it sure does represent a challenge.  Philips official position is
"Philips has determined that as a company we must encrypt data for privacy and security reasons. When writing a prescription file to an SD Card using Care Orchestrator, such a file will be created for a specific target device that can decrypt the prescription and other files that were created by Care Orchestrator "

This statement means they intend to deny patients access to detailed data.  The data may have keys that are specific to the machine serial number or have another decryption algorithm.  So far, we cannot support Philips Respironics machines in Oscar until that problem is solved. It would be nice to think we could call on Philips for help on this, but considering their obvious efforts to prevent patients from seeing their own data, and making them rely in a DME or physician, I'll let you calculate the odds.  Oscar is a non-profit, volunteer effort to enable patients to access their data.  Philips is setting an encryption on new machines to prevent this.  How much effort would  you suggest the volunteers expend to help Philips ?  People that want data without paying doctor fees or other access, will probably look elsewhere, and should.

Sleeprider,

Thank you for sharing.  Until I read this I was not aware that Philips was purposefully encrypting DS2 data to prevent patient access to what I consider critical information; I assumed it was just part of a typical software refresh that a company like Philips had implemented and that the development team was still working on it so to speak.  This is a significant reason why anyone inclined to monitor their treatment should avoid Philips.

For an analogy, I have been a T1 diabetic since childhood.  I have had an insulin pump for nearly 25 years and I also wear a continuous glucose monitor.  What Philips is doing by encrypting the data is akin to blinding a diabetic as whether they need insulin, or orange juice.  I find it despicable.

I voted with my wallet tonight.  I ordered a new Resmed Airsense Autoset 10 to serve as my new primary machine. If nothing else, it will divorce me from the emotional drama of what Philips will or wont do with this recall and whether it will take 30 days or 365 days.  My machine was 4+ years old anyway.  I also wont have to worry about the lack of Oscar support should Philips replace my DS1 with a DS2 down the road.

I wanted to wait for the Airsense 11, and I may still pick one up later, and have the A10 serve as a backup. If & when I have to fly for business travel I'll have to decide what to do about replacing the Dreamstation Go as well.

For anyone else interested, I was able to score the Autoset 10 for only $460 despite most online sellers having significantly raised their prices since the Philips recall.  I gave my DME the opportunity to match the price to keep my business, but they declined to do so.  I don't want to break any forum rules, so if anyone is interested in the vendor, just PM me.

[WakeUpTime]

I'm for keeping ResMed (or any other PAP system supplier) completely out of this Philips PAP Systems Recall thread, unless of course it's related to replacement system suggestions.  Even then, any positive or negative issues related to other PAP systems manufacturers, perceived or otherwise, could be best discussed in separate threads specific to those companies.  Other PAP system suppliers shouldn't be rumored to have similar Philips device defects, or related corporate issues, within this Philips systems recall thread.

Philips Recall FAQs

In the event of exposure to degraded foam: 

The potential risks of degraded foam 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 effects. 

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. 

During Philips' first quarter world-wide financial results conference call, here's where the Philips CEO further "lightly" covers the Philips Ventilator System Recall:

Koninklijke Philips N.V (NYSE : PHG)
Q1 2021 Corporate Results Conference Call
Apr 26, 2021, 4:00 a.m. ET

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

On the regulatory matters, regretfully, we have identified possible risks related to the sound abatement foam used in certain sleep and respiratory care devices currently in use and this is primarily related to the first-generation DreamStation product family. We are in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks. Given the estimated scope of the intended precautionary actions on the installed base, we have taken a provision of EUR250 million. I would like to flag that our latest CPAP platform, the DreamStation 2 is not affected as it is of a different design.

Noted in a subsequent financial release:  "Philips said it expects an increase of EUR250 million in costs, in addition to the provision of EUR250 million it booked in its first-quarter results."  [EUR500 million total, so far, or US$600M]

Immediately following the brief recall paragraph, the Philips CEO announces executive changes.  The executive formerly in charge of the Diagnosis & Treatment Segment (Rob Cascella) coincidentally is stepping down.  And so is the former Chief Innovation Strategy Officer (Jeroen Tas).  It would be interesting to interview them (under oath).

[RayBee]

Interesting discussion on the DS2 encryption and inaccessible data by the end-user. I hope this post isn't straying off topic too much.

That said, I wonder how many people will refuse a script for the DS2 based upon PR's M.O. to lock everything down. It seems likely that any over-the-counter un-scripted sales would be impossible too. So, is there enough of the foot being shot off by PR that they might change their ways on the DS2? I'm sure they are going to feel the pinch of end-users refusing all PR xPAP machines already. And I suspect this encryption scheme would alienate even more. But is it enough? Or are the self-titrate end-users too few in numbers to even be a blip on their radar? I can't even guess.

I think we may assume a good percentage of ApneaBoard members who love OSCAR will say "no thank you" to the DS2. But again, would our numbers be too few to even matter to them?

[cathyf]

Buddy, I don't know if the encryption is insurmountable, but it sure does represent a challenge.  Philips official position is
"Philips has determined that as a company we must encrypt data for privacy and security reasons. When writing a prescription file to an SD Card using Care Orchestrator, such a file will be created for a specific target device that can decrypt the prescription and other files that were created by Care Orchestrator "

This statement means they intend to deny patients access to detailed data.  The data may have keys that are specific to the machine serial number or have another decryption algorithm.  So far, we cannot support Philips Respironics machines in Oscar until that problem is solved. It would be nice to think we could call on Philips for help on this, but considering their obvious efforts to prevent patients from seeing their own data, and making them rely in a DME or physician, I'll let you calculate the odds.  Oscar is a non-profit, volunteer effort to enable patients to access their data.  Philips is setting an encryption on new machines to prevent this.  How much effort would  you suggest the volunteers expend to help Philips ?  People that want data without paying doctor fees or other access, will probably look elsewhere, and should.

OR -- perhaps Phillips has determined that their algorithm has some extremely dangerous feature to it, and they are encrypting the data to prevent the patients from observing the machine's behavior and discovering the danger that the machine puts them in.

Before last week I would have said that was a silly and paranoid thought. Now my first response to the information that PR is encrypting data is "what are they hiding and how bad is it?!?"