Phillips / Philips Respironics recent recall notice discussion thread

[HairyReasoner]

I don't know how many have seen this, but The Medicine and Healthcare products Regulatory Agency is the UK's version of the FDA. They seem to be downplaying the risks of the foam. They cite "currently available data" to say several of the VOCs dissipate after 24 hours out of box. Another one is "within an acceptable margin of safety." Overall, they seem to downplay the risk--particularly in relation to stopping treatment.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

[Dan_McD]

I don't know how many have seen this, but The Medicine and Healthcare products Regulatory Agency is the UK's version of the FDA. They seem to be downplaying the risks of the foam. They cite "currently available data" to say several of the VOCs dissipate after 24 hours out of box. Another one is "within an acceptable margin of safety." Overall, they seem to downplay the risk--particularly in relation to stopping treatment.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

I don't trust any government agency. Especially the UK. Every agency can be bought off, just like our FBI,CIA,DOJ ETC.ETC.
BTW. Lets get that data out there. You know, that "currently available data". How many times have we heard that?
How many cases? How many complaints? When did they first do testing? How long have they known? Were brand new machines blowing VOC's?

[ChicagoGranny]

I don't know how many have seen this, but The Medicine and Healthcare products Regulatory Agency is the UK's version of the FDA. They seem to be downplaying the risks of the foam. They cite "currently available data" to say several of the VOCs dissipate after 24 hours out of box. Another one is "within an acceptable margin of safety." Overall, they seem to downplay the risk--particularly in relation to stopping treatment.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

Ahhh, a much more reasonable approach as compared to the U.S. the-sky-is-falling culture and hordes of ambulance-chasing lawyers.

Thanks for posting this!

[chunkyfrog]

I am inclined to agree, granny.
No doubt Respironics wants to avoid litigation;
but how would the toxic materials implied ever be allowed to enter the factory--
much less get incorporated, packaged, and shipped out?
OK, plausible deniability, maybe . . .
---But in a US-based factory?
Really?
[While tv footage plays of the "death condo"]

[Grumpy48]

I am inclined to agree, granny.
No doubt Respironics wants to avoid litigation;
but how would the toxic materials implied ever be allowed to enter the factory--
much less get incorporated, packaged, and shipped out?
OK, plausible deniability, maybe . . .
---But in a US-based factory?
Really?
[While tv footage plays of the "death condo"]

Parts and pieces manufactured China, shipped to and assembled and tested in the US(?)

[chunkyfrog]

Yikes! Chinese parts . . .
Remember when Chinese baby formula had melamine powder added,
because melamine falsely tested as protein, and the formula could be made cheaper?
This was their own children, and many died.
Somebody was said to be executed for their part, but ? . . .

[Davidtoo]

I just started using the Dream station in the middle of February, and used it up to seeing the recall notification a few days ago. I've got mild sleep apnea so can do without a machine for now, but I am a little concerned about the potential injury.

Watching Youtube videos where the Dream Station is taken apart, it seems that this foam is sealed away from the turbine propeller by plastic. If the air is not passing through the foam or over or under it, how then does the foam or gasses get around the plastic into the propeller to cause injury?

I can't say that I noticed any symptoms from using the Dream station other than (1) I noticed I had to clear my throat a lot more often than before and (2) I do not like the machine. I find it difficult to breath through the mask. I honestly don't know if it was doing me any good or not, but I have been using it at best 4 hours at night up to 70% of the time, and then only begrudgingly. I am not sleepy during the day without it, I used it only because my oxygen saturation was at times dipping into the 80's during the evening. Now the question is whether I should get another machine or just live with mild sleep apnea for now. My pulmonologist recommended using one originally...but now I am not so sure.

[reader2580]

Philips is a worldwide company that is headquartered in the Netherlands. Do you really expect them to manufacture all of their stuff in the United States? I highly doubt that Philips didn't know exactly what type of foam was going into their products. I find it hard to believe that Philips would have not noticed a supplier supplying the wrong type of foam across multiple generations of product for years on end.

The chances of Philips Respironics CPAP machines not having at least some parts made in China is pretty slim in this day and age.

[chunkyfrog]

Like I said----plausible deniability . . .
Investigate to reveal who did know, or chose not to know--and then buy a rope!

[Dan_McD]

It is interesting how the UK could conclude that Philips’ own recall is not serious and null and void. Just keep using your machines that may cause cancer and or all the throat, nose, and skin irritation you have been experiencing is all in your mind. “The sky is not falling.”

But then again, the England Lung Foundation asked Philips Responics 6 questions about the foam degradation and this was Philips response.

1. This figure is not known at present…
2. We do not have information yet…
3. At the moment it is not clear how long this process could take…
4. We do not have information about the material…
5. All affected machines will be replaced or refitted…
6. Studies have already started and will be ongoing…

Questions asked to Philips from the ELF Sleep PAG

How many devices in Europe are part of the recall including CPAP /APAP/Bilevel and presso-volumetric, and specifically how many units are in each country of the 27 member states?

This figure is not known at present and will need to come from the regulators.

Can you confirm that the German regulatory body coordinating the regulatory bodies will give some plans for EU by the beginning of next week?

We do not have information yet how the process of the national regulatory boards will be and how it will organized on the EU level. We may get information this week.

When do you expect to replace all the devices covered by the recall, with the new dreamstation 2 model and with the new noise abatement (reduction) object?

At the moment it is not clear how long this process could take. However, it could realistically take 12 months or more.

What material was the turbine noise abatement (reducer) made of?

The current material is Polyester polyurethane. We do not have information about the material in other devices yet.

Will System One and Dreamstation 1 machines older than 5 years be replaced?

All affected machines will be replaced or refitted.

Does Philips plan to support and promote research studies to assess the health impact this carcinogenic (cancer causing) material may have on patients in the medium to long term?

Studies have already started and will be ongoing.

https://europeanlung.org/en/news-and-bl ... y-failure/

"All affected machines will be replaced or refitted." Is this serious??

[chunkyfrog]

. . . . EVENTUALLY
"realistically, 12 months or more"
You can count on the " or more".

[Davidtoo]

I don't know how many have seen this, but The Medicine and Healthcare products Regulatory Agency is the UK's version of the FDA. They seem to be downplaying the risks of the foam. They cite "currently available data" to say several of the VOCs dissipate after 24 hours out of box. Another one is "within an acceptable margin of safety." Overall, they seem to downplay the risk--particularly in relation to stopping treatment.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

Ahhh, a much more reasonable approach as compared to the U.S. the-sky-is-falling culture and hordes of ambulance-chasing lawyers.

Thanks for posting this!

A reasonable approach is to pretend there is not an issue with the machines when Phillips has come out and admitted itself there are potential dangers caused by the foam? What do "ambulance-chasing lawyers" have to do with anything. You can be sure it is those "lawyers" who Phillips considered before going public with the dangers of their own machines...its called attempting to mitigate damages. Obviously if the machine does cause cancer, or pulmonary fibroses or other serious medical events, the damages to Philips could be huge. Better to nip it in the bud early on and attempt to show you are being proactive, rather than going the Firestone Tire route and making a financial decision about how many people will be killed by exploding tires and figuring out the financial cost of paying off for those deaths vs. fixing the problem.

[ChicagoGranny]

What do "ambulance-chasing lawyers" have to do with anything.

The ambulance-chasing lawyers have everything to do with it. They are what the Philips lawyers are advising against.

The Philips lawyers are evaluating the financial and legal risks for Philips. They are not evaluating the supposed health risk.

[Davidtoo]

What do "ambulance-chasing lawyers" have to do with anything.

The ambulance-chasing lawyers have everything to do with it. They are what the Philips lawyers are advising against.

The Philips lawyers are evaluating the financial and legal risks for Philips. They are not evaluating the supposed health risk.

Exactly, the lawyers play a crucial role. On the one hand, the "ambulance chasing lawyers" will hold Phillips accountable, and it should be accountable, for its negligence while the company lawyers will attempt to shift fault or blame to others than Phillips, like onto the ozone cleaning companies, or will attempt to deny injury. Sure people may come down to with cancer, which Phillips has admitted is a possible outcome of the degraded foam, but although Phillips will admit that possibility, they will also claim in each individual case of cancer that there is no evidence the cancer was linked to the foam. I.e., it will attempt to have it both ways, challenging liability and causation all while being the good guys and admitting there is a problem with the foam. It is all a strategic plan, and the potential lawsuits were a big consideration of how they have handled this.

[Dan_McD]

Davidtoo post_id=1388909 time=1625853283 user_id=98663

A reasonable approach is to pretend there is not an issue with the machines when Phillips has come out and admitted itself there are potential dangers caused by the foam? What do "ambulance-chasing lawyers" have to do with anything. You can be sure it is those "lawyers" who Phillips considered before going public with the dangers of their own machines...its called attempting to mitigate damages. Obviously if the machine does cause cancer, or pulmonary fibroses or other serious medical events, the damages to Philips could be huge. Better to nip it in the bud early on and attempt to show you are being proactive, rather than going the Firestone Tire route and making a financial decision about how many people will be killed by exploding tires and figuring out the financial cost of paying off for those deaths vs. fixing the problem.

What do "ambulance-chasing lawyers" have to do with anything.
the-sky-is-falling culture and hordes of ambulance-chasing lawyers.

Hyperbole definition is - extravagant exaggeration (such as 'mile-high ice-cream cones').