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

[btreger]

Australian Government
Department of Health

Device repair/replacement program - progress update

16 December 2021

Approximately 20% of the affected devices registered with Philips in Australia for correction have now been corrected under the repair/replacement program. Users are reminded that registration at https://www.philipssrcupdate.expertinquiry.com(link is external) is vital to ensure you receive the repair or replacement of your device.

In addition to the DreamStation CPAP and 50 Series CPAP, the repair/replacement program for DreamStation BiPAP devices has now also commenced. Philips has advised the repair/replacement for the following devices will also commence in December 2021-January 2022:

DreamStation ASV
DreamStation ST, AVAPS
50 Series ASV
C Series ASV (60 Series)
C Series S/T AVAPS (60 Series)

If you require assistance to set up your replacement device please contact Philips at 1800 830 517 (Option 1). If required, Philips may arrange an in-clinic assessment to assist you.

You can verify that your device no longer has the impacted PE-PUR foam by checking the label for a 'UDI' field which is being included on all repaired devices (as shown in the before / after label pictures below):

In the event you have an upcoming surgical procedure and have not received a repaired or replaced device, please advise your clinician prior to your procedure (as early as possible) that you use an affected device and speak with them about ongoing use following surgery.

Updates on the supply of CPAP, Bi-Level PAP devices, and mechanical ventilators
Philips is currently working to manufacture enough devices for users affected by the issues with PE-PUR foam. Given this, they are unable to fulfill orders at this time for new patients requiring CPAP or Bi-Level PAP devices.

Supply of Trilogy Evo ventilators has resumed for new patients requiring ventilation, noting this model supersedes the Trilogy 100 model.


https://www.tga.gov.au/alert/philips-rec...entilators

[Moriarty]

Australian Government
Department of Health

Device repair/replacement program - progress update

16 December 2021
….

Thanks for that….

[jpsantell]

Since I registered in July I haven't gotten a single email from Phillips beyond the verification email. They're customer service sucks! The only place I get any news is right here on the forum. Jeeze!

[ST Dog]

I'm not sure how the Philips-commissioned testing company will be able to effectively test for the impact on several million patients of various pre-existing health conditions, ages, environments, ventilator models, ownership times, pressure conditions, environment temperatures and humidity levels, future health illnesses, etc.  

They are measuring the off gassing from the foam over a period and extrapolating from that. Basic science.

Given those results they can estimate exposure to various chemicals over time and determine if those level are medically significant.

So if you used the machine for 2 years, 5 years, or even 10, would you be exposed to chemical in amounts expected to cause harm.

That doesn't include testing for deterioration and inhalation of foam particles. But not all machines have such deterioration nor are they passing foam particles. So the VOC testing is good data for those with machines in that condition.

[WakeUpTime]

That doesn't include testing for deterioration and inhalation of foam particles. But not all machines have such deterioration nor are they passing foam particles. So the VOC testing is good data for those with machines in that condition.

That's what I find misleading about the Philips-commissioned "independent" lab study on the Philips faulty foam.  In my real-life understanding of component-breakdown, items don't breakdown in a linear consistent fashion.  Off-gassing also isn't a linear breakdown.  Extrapolating over 1-, 5- and 10-year periods would seem to be just a wild estimate for real-life outcomes.  

For example, when studying the breakdown of a plastic bag in a landfill, there are significant variables and variations (wind, temperature, air pressure, previous usage, sunlight, future movement, degree of compression, etc.)  For a lab to come out and say that a specific bag will breakdown completely in 120 years would seem to be extremely inaccurate in reality.  Automotive manufacturers frequently use lab science to predict the lifespan of components, however real usage in a substantial number of variable environments have shown those estimates to be completely faulty and inaccurate.

I'm reminded of how Ikea, many years ago, used to show in stores a testing machine for chairs and sofas that simulated long-term use in order to show how their seat cushions would last 20+ years.  With no disrespect to Ikea, in reality, most of their chairs and sofas did not last 20+ years.  Amongst other things, Ikea's simulation scientists likely didn't account for little Johnny's friends visiting and having a sofa-jumping party several times a year - and a thousand other real-life variables.  (Simulation versus reality.)

The Philips "independent" laboratory study also likely used preset environmental and patient conditions, although they may have varied them for testing purposes.  Let's not rule out the possibility that Philips chose the conditions that produced the best results for Philips.  After all, millions, or even billions, of settlement dollars may be on the line.  

Reality trumps lab studies every time.  By storing and having a truly independent agency examining random foam components from the returned machines, a realistic understanding of the foam breakdown would be realized.  Suggesting significant breakdown of the foam is due to return-shipping, etc., is a gross underestimate of the likely inhalation and digestion of Philips faulty carcinogenic foam particles.  

Did the Philips-commissioned "independent" laboratory study account for the following real-life variables:
- users may travel with the xPAP device, taken it on a plane several times a year (pressure variations, movement, etc.)
- users may take the xPAP device camping or to other environments (varying movements, temperatures, humidity, pressure, etc.) 
- users may have taken their xPAP device to their DME for periodic scheduled maintenance (cleaning, etc.) 
- etc.

The general population is having a little too much fun with the phrase "trust the science".  There are many situations when science can be manipulated to produce virtually any desired result.  Also, science is often true until updated future science proves that it wasn't.  I'm not anti-science by any means but history has shown how companies have frequently sold the public on 'scientific research' that has later proven to be extremely erroneous.

All of the above may not matter much as ultimately the influential authorities that will shape the outcomes for Recalled device owners will be the FDA and other country medical agencies - and of course the individual judge in any class-action lawsuit.

[btreger]

Philips Testing

The recently released results Philips released was an update on the results they released after the initial recall, the original foam used in DS1's and other recalled machines.

This is not the testing the FDA requested in mid November:

However, while conducting a recent follow-up inspection of a Philips manufacturing facility as part of its efforts to identify the root cause of the initial issue, the FDA was given new information showing less than favorable results for the replacement foam in one device marketed outside of the U.S. In that case, the machine—equipped with the new material—failed a safety test studying the release of volatile organic compounds within the device.

The agency has since asked Philips to select an independent laboratory to test the silicone-based foam to identify any potential safety risks and their scope.

We are still waiting for those results. I think Philips is trying to confuse everyone into thinking that they have now complied with everything the FDA has requested from them with their latest news release.

The facts are they have not. The FDA and all of us are still waiting for those results requested in November.

[ST Dog]

Philips-commissioned "independent" lab study o

Your repeated use of that phrase tells me all I need to know. Nothing Philips does will, satisfy you.

So until some 3rd party ponies up a few million dollars for testing you won't be happy and I just don't see any group going that.

All companies pay for outside, independent (as in not part of the company) labs to for things. And no lab worth it's name lets the company that hired them influence how the testing is done or reported.

That's the only way the system works. Only the company wanting to market a product is going to pay for the testing (or an entity wanting to discredit another).

As for the rest.

IKEA, you used examples of abuse and improper use of a couch to discredit their testing. My screwdriver is a great tool but if I use it as a pry bar or chisel it won't last either.

The bag may not break down in exactly 120 years, but it'll be close. They sure can't wait 120 years before it's on the market.

It's the system we have. If you won't trust it a little then don't use anything. Not a CPAP machine, RX drug, OTC drug, a motor vehicle, the materials to build a house. And for sure no food at a grocery store or restaurant.

[ST Dog]

I think Philips is trying to confuse everyone into thinking that they have now complied with everything the FDA has requested from them with their latest news release.

They clearly state what they were testing. I had no difficulty discerning what foam they were testing.

Since then, together with certified testing laboratories and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). Philips Respironics is now providing an update 

And they state first generation Dreamstation, not DS2, not repaired/replacement machines.

The silicon foam testing is not part of the recall. It's a separate issue.

Nothing In that release supports your assertion that Philips is trying to confuse anyone.

[btreger]

More From Philips 

On December 15, in open court, a Philips defense attorney cited a Canadian study spanning 9 years of Respironics use by consumers and didn’t find any association with elevated cancer.  He further stated that this was a peer-reviewed study.

No one has to this point been able to find any evidence this study existed. I even asked the Canadian Thoracic Society for their help.

Now on December 23, Philips released a news update stating, "Philips provides an update on the test and research program in connection with the CPAP, BiPAP, and Mechanical Ventilator recall notification".

It is my belief that the Philips attorney's comments were thrown out in anticipation and knowledge of the December 23 news release. That news release does not mention Canada, does not mention a 9-year study, or that it was peer-reviewed. 

Who really knows, maybe there are more studies to come. The Canadian one and the one the FDA asked for.

[hegel]

I agree with St. Dog. the whole "science can be used to fudge results so trust my unfounded opinion instead" argument is absurd. It's also in line with the whole "trust Q anon and other random sources on the internet over actual science and the NYTimes etc. zeitgeist that's being peddled lately. 

I'd caution readers not to accept as fact everything on this thread that'[s being asserted. It will lead to unwarranted anxiety. IT may yet turn out that all of the worst fears about the PR foam come true (I doubt that, but it's possible). It could also turn out that very few people have been affected. Posters here are ready to hang PR without a trial in a form of internet mob action. Never a good idea.