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

[btreger]

Having one all-encompassing thread when their are so many related subjects will be a challenge for viewers to go through.  Ideally, this one general thread might have its own group of sub-threads, if it's indeed true (from a previous HME magazine U.S. survey) that as many as 60% of end-users may be using Philips (now recalled) systems.  If that's still true today, it's a massive shock to the industry where 60% of PAP users are immediately instructed to halt using their PAP machines, and without being provided with an immediate future "fix" or replacement, for a medical device that's deemed necessary for most users.

There are indeed many possible related sub-topics to the Philips Recall:

- Philips corporate news, that may be related to the recall
- Other manufacturers foam and company responses
- Developing legal actions from end-users
- Foam-removal steps for recalled Philips systems
- Philips recall in other (non-U.S.) countries
- Analyses of Philips defective foam (photos, reports, etc.)
- etc.

Regarding Philips' Q1-2021 increase over Q1-2020, I suppose the massive ventilator sales revenues didn't come in until perhaps after March 2020, as a result of COVID.  Early Q1-2020 purchases might have just been to wipe-out Philips dealer inventories of invasive ventilators, and didn't represent new sales directly from Philips.  It'll be interesting how Q2-2021 sales compare to Q2-2020.

It will be interesting how quasi shipments are reflected in future sales and earnings reports:
- shipments of DreamStation 2 units to replace dealer-returned DreamStation 1 units
- shipments of DreamStation 2 (and other Philips units) to replace newer recent purchases by users, hospitals, sleep centers, etc.
- complimentary shipments of DreamStation 2 units to dealers to entice them back to marketing the Philips brand to users

Philips has already taken the "EURO 500 Million" charge over two different quarters to spread it out.  That represents merely $170 per Philips recalled system, assuming there are 3.5 Million recalled devices.  The only step Philips has taken (for end-users) is to request registration details - and instruct them to stop using their machines (see their doctor, etc.).  Philips likely has no real accurate number of actual active recalled Philips machines.  

This is going to take a significant amount of time to complete in the U.S. and internationally.  Philips may be counting on that as they prefer costs to be spread out over multiple quarters, so-as not to more dramatically affect their ongoing stock price.  Sadly, the ongoing COVID-related issues in 3rd world countries (that may last another year or more) may significantly benefit Philips financially, from sales of invasive ventilators.  The strength in current & future sales of those units will help to offset the recall costs within this product division.  Also, many countries are now investing significantly more for their country's medical reserves for potential future needs.  Philips will have to sufficiently accommodate all countries if they hope to continue selling other medical systems, unrelated to the recall.



I believe the financial cost to Philips is going to grow continually as class-action lawsuits develop and other countries begin to demand action from Philips.  Some of those countries may have quite socialized medical systems, with the country actually be the "purchaser" rather than a DME.  They may simply demand (quietly) that Philips immediately replace (or "fix") their (e.g.) 20,000 defective units - if Philips wishes to continue to have access to that country.  Working with a country, rather than a small DME, is quite a different experience altogether.  

Philips is likely taking a more personalized approach to all other countries.  There is likely ongoing communications between the Philips country representative and their respective countries.  All E.U. countries are likely grouped together in a response, however Philips might get a lot of corporate protection too from the E.U.  Canada is part of the U.S. recall I believe.  Australia's in an interesting position, as they really don't need Philips, but the E.U. might retaliate.  I'm not sure about others.



Indeed.  That will result in a lot of related consequences for Philips, and others.

There are indeed DME's in Europe I found after doing a small search. They seem to work like ours in some respects. You do need a prescription, does not require a specialist, your regular doctor can write it. They do not seem to be covered by insurance, but it appears you would have to purchase them yourself. On one site I found a least two of the recalled Philips machines

[WakeUpTime]

I contacted my Dr, who initially told me to discontinue use of the machine.  

We're very grateful that you related your experience, as there are likely thousands of others (silently) going through similar experiences at this moment.  You've highlight several areas that are significant parts of the recall, that Philips has not directly addressed:

- compensation for the out-of-pocket costs associated with the immediate replacement of the end-users defective device (new machine cost, possible DME service costs for setup and re-training, etc.)

- medical claims for any previous or on-going use due to the possible harmful effects as a result of ingestion of the defective foam particles

- possible liability due to corporate negligence in not notifying Philips end-users many months (or years) earlier, prior to Philips getting reports of foam issues and re-designing the foam in the DreamStation 2

- new service fees associated with a possible replacement to our defective Philips machines (setup fees for the refurbished or replaced system, etc.)

Philips merely committing to a long-term future "fix" to the defective and harmful foam is absolutely insufficient for a medical device proven to be medical necessary for its users.

[Psikic]

The Dr gave me a new prescription right away and I bought one out of pocket (and for less than the original insurance CoPay on the DreamStation!)  and it has been working great.  

I forgot to mention -- the new DME loaded the existing pressures for me on the AirSense, which were working well with the DreamStation.  However, the pressures on the AirSense were NOT ENOUGH.  I had to manually increase the pressures (from 10-12 on the Dreamstation) to (11.6-13.6) on the AirSense because the AirSense for some reason does not blow as much air.  This is after making sure the mask type and hose type were set properly.  

I really do hope that Philips compensates me for the out of pocket ResMed, but in all honesty, I don't care.  If they want to fix my old DreamStation, I'll be happy to keep it around as a backup, but I don't plan to continue using it unless the ResMed needs to go in for service or something.  I'll be perfectly fine to continue using the new ResMed and leave Philips behind.  For that matter, I don't plan to buy any Philips dental products, or even Philips light bulbs anymore.

[WakeUpTime]

If they want to fix my old DreamStation, I'll be happy to keep it around as a backup, but I don't plan to continue using it unless the ResMed needs to go in for service or something.  

I find it absolutely incredible that government agencies (so far) are accepting as a "sufficient response" Philips plan to provide repaired-systems (many months from now) that will be merely used as backup systems - after having been immediately forced (for medical and product-defect reasons) into the re-purchase of another PAP system.  

This is not equivalent to a recall of a defective toothbrush, yet its being treated as such.  This is more like having a recall on a defective pacemaker, where a person is required to immediately get it replaced with an alternative product. 

Would it be "sufficient" for the manufacturer of a pacemaker

that is known to have disintegrating and cancer-causing compounds

to provide a refurbished unit in 3-6 months? 

How is it that government agencies are not treating this neglectful and insufficient corporate response with the seriousness that it deserves?  At the moment, almost all of the media is merely reporting the content of the Philips recall, based on the Philips corporate announcement.  Almost no one in the media is reporting on the total practical implications of the recall on the medically-dependent end-users.  

Philips has allocated a $170 cost to each defective yet,

but many users will be out-of-pocket 3-10X that amount

through no fault of their own.

[btreger]

I find it absolutely incredible that government agencies (so far) are accepting as a "sufficient response" Philips plan to provide repaired-systems (many months from now) that will be merely used as backup systems - after having been immediately forced (for medical and product-defect reasons) into the re-purchase of another PAP system.  

This is not equivalent to a recall of a defective toothbrush, yet its being treated as such.  This is more like having a recall on a defective pacemaker, where a person is required to immediately get it replaced with an alternative product. 

Would it be "sufficient" for the manufacturer of a pacemaker

that is known to have disintegrating and cancer-causing compounds

to provide a refurbished unit in 3-6 months? 

How is it that government agencies are not treating this neglectful and insufficient corporate response with the seriousness that it deserves?  At the moment, almost all of the media is merely reporting the content of the Philips recall, based on the Philips corporate announcement.  Almost no one in the media is reporting on the total practical implications of the recall on the medically-dependent end-users.  

Philips has allocated a $170 cost to each defective yet,

but many users will be out-of-pocket 3-10X that amount

through no fault of their own.

Excellent points. I guess it would asking too much to think that now that the FDA is involved, they would not wait another 12 years to go through this process again, and would fully inspect, and certify the new DremStation II product line now.

These are some of the languages in one of the pending Class Action Law Suits:

First I must state that I am not for or against these suits. Everyone on this thread must make that decision for themselves.

“This important class-action lawsuit seeks to recover all damages suffered by consumers who purchased the recalled CPAP devices and have Philips replace them free of charge with safe and effective devices. It is outrageous and we look forward to fighting on their behalf to obtain a resolution with Philips that provides damages for their economic and personal injuries.

[WakeUpTime]

Not wanting to risk violating any forum rules, I searched your quoted last sentence to find the law firm in that one (out of several) class action lawsuits.  It's extremely gratifying to finally here the terms "economic" damages (in addition to personal health).  It's very appropriate, and something that Philips absolutely can't dispute or minimize.

"It is outrageous and we look forward to fighting
on their [Philips recalled device users] behalf
to obtain a resolution with Philips that provides damages
for their economic and personal injuries."

[qwerty42]

Interesting -- thanks for the extra info. Here's a diagram I made in case anyone's interested. The only sensor that would be affected by cutouts to remove the foam is the one I labeled #2 -- but it's a very important one, unfortunately. Cutouts downstream of it (meaning further along the path toward the blower intake) won't change its readings, but cutouts upstream of it (toward the inlet filter) will cause it to read erroneous values.

That particular sensor, since it's measuring flow rate, is probably being used to determine obstructions, hypopneas, clear airway apneas, and basically everything else except for the actual pressure in your hose, so it's very important that it is working correctly.

I can't tell from the pictures I've seen whether or not the foam plays a role in its measurement. There are a few different ways it could be configured to take this measurement (measuring static pressure on either side of a restrictor; or using a static pressure port and dynamic pressure port like a pitot tube; or diverting airflow directly through it if it's actually a dedicated mass airflow sensor). I'd need to take a closer look at that middle section of the foam chamber and see where the ports go and how they're shaped to know which of these it is. If I have time this weekend I'll take apart my own DreamStation and reverse engineer this definitively for you all.

Hi all, your local mechanical & aerospace engineer here. I took my Dreamstation apart today and now have definitive info about my earlier guesses:

• The sensor labeled 1 is indeed a humidity sensor. Labeled SHT20 D6UYU, it's a Sensirion humidity sensor IC which also measures temperature.
  
• The sensor labeled 2 is indeed a differential pressure sensor (Sensirion SDP703-02), and I've confirmed it's measuring mass flow rate. In the plastic "tank" where these pressure ports connect, there is a white plastic grating which acts as a slight flow restrictor. By measuring the pressure delta across this restriction, the machine can calculate mass air flow rate. It is actually capable of bi-directional flow rate measurement as long as they coded their firmware to calculate both directions.
  
• The sensor labeled 3 is indeed another differential pressure sensor (C02069 NPA1711008). The part number appears to be a specialty configuration, but it's based on a readily available Amphenol NOVASensor pressure sensor. This one is measuring the output pressure of the blower (meaning your mask and hose pressure too), and is referencing it to ambient atmospheric pressure through the second port.
  

Based on my teardown and inspection, I can say with a high degree of confidence:

1. The foam does *not* need to be in the unit for any of these sensors to work. However, the void left by removing the foam might introduce a bit of extra turbulence/vorticity in the flow, which could make the mass airflow sensor less accurate. My gut feeling here is that it probably won't make a big enough difference to matter, but I can't say this definitively without a lot more involved analysis and/or testing.
   
2. Any cutouts made to remove the foam upstream of the differential sensor (the pair of side-by-side ports where sensor #2 connects) must be sealed back up, airtight, for the sensor to measure mass air flow correctly. Ideally, any cutouts on the downstream side should be covered too, but they shouldn't make any difference to this sensor even if they aren't.
   
3. If you cut into the chamber to remove the foam, it'd be best to keep your cuts well away from that middle section where sensor #2 plugs in, because rough edges there could create flow trips which might affect the accuracy of that flow sensor's calibration.
   

[S.Thompson]

qwerty42... YOU are flat out awesome. Plain simple truth dude. Many thanks.

[qwerty42]

qwerty42... YOU are flat out awesome. Plain simple truth dude. Many thanks.

Thanks, and you are very welcome! Glad to be able to help with this whole saga.

[cathyf]

qwerty42 -- having done this teardown, how do you think they got the foam in there? If you were going to engineer a process to remove the foam and replace it with a different material, how would you do it?

I wonder if you could use the tools of laproscopic surgery to get the old foam out and new foam in by going through the air intake/outlets?

Phillips' complete passivity through all of this is just astonishing to me. The engineer in me would want to be figuring out how to re-calibrate the machines for foam-free operation, at least.

As a legal strategy, that would be an interesting demand for the class-action lawyers to bring. Demand that Phillips reprogram the machine of all the users who have removed their foam and do it NOW.