Phillips / Philips Respironics recent recall notice discussion thread

[Pugsy]

Not fair to call them BOTH out. IMHO.

Well...actually I have always thought it takes at least 2 to have a pissing contest of any kind.
Been there and participated in my own share of pissing contests.

Someone always starts it and someone always wants to "get the last word in"....been there done that.
It always takes at least 2.

To everyone else......

Folks....please ....this thread is to help people and not an arena to bash Respironics or the FDA or each other.

Go somewhere else for the shit talk....don't trash my thread with it.

Everyone knows I only give one warning and this is it. It's my thread and I get to have an opinion about it and if someone doesn't want to abide by my wishes....so be it...but go somewhere else.

Stay on topic please and I think we all know what the topic is....or risk posts being removed. This thread will NOT become another pissing contest thread....and I can do something about it...and everyone knows that I am not afraid to do it.

[Sea Papper]

Not fair to call them BOTH out. IMHO.

Well...actually I have always thought it takes at least 2 to have a pissing contest of any kind.
Been there and participated in my own share of pissing contests.

Someone always starts it and someone always wants to "get the last word in"....been there done that.
It always takes at least 2.

To everyone else......

Folks....please ....this thread is to help people and not an arena to bash Respironics or the FDA or each other.

Go somewhere else for the shit talk....don't trash my thread with it.

Everyone knows I only give one warning and this is it. It's my thread and I get to have an opinion about it and if someone doesn't want to abide by my wishes....so be it...but go somewhere else.

Stay on topic please and I think we all know what the topic is....or risk posts being removed. This thread will NOT become another pissing contest thread....and I can do something about it...and everyone knows that I am not afraid to do it.

Sorry Bud, I thought the topic is "Phillips Respironics recent recall notice discussion thread" Read that somewhere.

[Sheffey]

100s of FDA adverse event reports a day and they kept on merrily shipping the product.

This is total baloney.

There were only 8 reports in the first quarter of this year and 20 in last year that included CPAP in the report. Not a single one of these reports involved the current recall. All of them involved drugs taken in conjunction with CPAP. Look them up yourself - https://fis.fda.gov/sense/app/d10be6bb- ... e/analysis
.

FAERS CPAP.jpg (46.32 KiB) Viewed 23050 times

[Pugsy]

Sorry Bud, I thought the topic is "Phillips Respironics recent recall notice discussion thread" Read that somewhere.

I am not a "Bud" for one thing....
and the topic isn't for the bullshit attacks you are posting. It's NOT for just wanting a platform to air your bitching.

It's to notify people about the recall...help them figure out if their machine is affected or not and help them decide what to do.

It's not a platform for bashing Respironics or the FDA because someone should have done something differently.

Continued attempts to just stir up trouble will result in post removal and posting privileges removed.
Go elsewhere with your rants and stirring up trouble attempts.

[chunkyfrog]

. . .
this "wait and see" thing.

Any doctor who tries to say "Wait and see." to me gets reminded that
I had BREAST CANCER. Caught early--cured quickly.
Luckily, I was not told to wait and see.

[Air Jordan]

Have there been any complaints in cpaptalk about problems with the foam? I did a search and couldn't find anything.

[Muddpa]

Hi Pugsy and group,

OK do I panic at this point. I get my DreamStation from the VA. As of yesterday their answer is no answer. They are saying they see the issue and at this time use it at your own risk. They have no plan. Has anybody Doctor or DME come forth with any ideas. I'm not beating up PR. I would just like to get a honest answer.

[amenite]

I just noticed the "Q Series" is anything labeled "System One" as pictured near the bottom of the page on the Philips recall notification page under category "Non-continuous Ventilator":

https://www.usa.philips.com/healthcare/ ... src-update

It's the only reference I've seen to "Q Series"

[Desert mans wife]

The one thing I wish I knew is if it takes some time and use for the foam to start degrading or outgassing. I wish I knew if my 1 month old machine is safe.

[palerider]

Is it just a matter of time before lawyers get to ResMed?

Who knows.

It might not be the same kind of foam.

That's foam that was in a machine with a couple thousands hours of use, so who knows.

[Pugsy]

I just noticed the "Q Series" is anything labeled "System One" as pictured near the bottom of the page on the Philips recall notification page under category "Non-continuous Ventilator":

https://www.usa.philips.com/healthcare/ ... src-update

It's the only reference I've seen to "Q Series"

I covered the "Q" thing more than once here.
We don't know what it means. No one that I know has ever seen anything that distinguishes "Q" System One machines from any others.
I tend to think it is an internal general classification and not a particular label.
I could be wrong though. My source who works in the business...agrees with me.

In any regard...assume the worst and plan accordingly. I think that pretty much all the System One machines, with the exception of a couple of very high end ventilators, are affected. Pretty much all the models that are run of the mill cpap/apap/bipap System One models.

It would have been nice if someone at Respironics explained "Q series" in more detail but they haven't done that yet and until they do...we assume the worst because that is the most cautious option.

[palerider]

Philips obviously broke Federal Law.

What Federal Law did they break and how did they break it? Please be specific.

Technically speaking, any medical device recall is due to the manufacturer violating federal law

This is patently false.

- (1) The patient-contacting components of the device must be demonstrated to be biocompatible.

That, is referring to the MASK. the part that contacts the patient.

[Sea Papper]

Philips obviously broke Federal Law.

What Federal Law did they break and how did they break it? Please be specific.

Technically speaking, any medical device recall is due to the manufacturer violating federal law

This is patently false.

- (1) The patient-contacting components of the device must be demonstrated to be biocompatible.

That, you fool, is the *MASK*. the part that contacts the patient.

So the pressurized air coming from the machine does not come in contact with the patient's body? Here's a hint, its called "Blood path, indirect" in ISO 10993-1:2009.
I'd give you a solid debate but this forum is all about gumdrops, rainbows, unicorns, and calling people derogatory names if they don't praise Philips-Respironics.

Yay Philips-Respironics is the best-est!

[Pugsy]

this forum is all about gumdrops, rainbows, unicorns, and calling people derogatory names if they don't praise Philips-Respironics.

This is the last time your smart ass remarks will remain...that was uncalled for and blatantly untrue and said just to provoke and inflame (which it did accomplish that goal) and I am tired of it.

Futher such comments will disappear. If I have to edit your posts too many times ....maybe it would be just better if you didn't post at all and I can sure do that was well.

People get called derogatory names when they are assholes in general...not because they don't praise someone or something or even Respironics. We all know they could have handled this differently or better and I myself have said there is more to it than meets the eye but continued bull shit attacks accomplishes nothing and it has derailed my thread...and pissed me off.

Your choice....quit being an asshole or not post here. You know exactly what you are going and I am done letting it slide hoping you will grow up and play nice.

I repeat....this is not a thread about bashing Respironics...that wasn't the goal. It was to help people figure out or understand the ramifications of the recall notice. Bashing Respironics at this point accomplishes absolutely nothing.
Yeah, they handled things poorly....get over it and move on....we can't fix that problem here and no since derailing my thread with this horseshit.

[HairyReasoner]

I noticed this in the FAQ section of the recall update in answer to the questions: "How did this happen, and what is Philips doing to ensure it will not happen again?"

"Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue.

The products were designed according to, and in compliance with, appropriate standards upon release. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Philips Quality Management System has been updated to reflect these new requirements.

However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

Philips has been in full compliance with relevant standards upon product commercialization."


So, this makes me wonder if the problems with the foam are only considered dangerous in relation to newer, updated standards rather than it being something that would have been considered a problem when the machines originally came out. Is it a case where the standard tightened to put the product in violation rather than the product being in violation all along?

To use an example, a few years before I bought my house it would have passed a radon test because it was below the level then considered dangerous. But, by the time I bought the house, the EPA (or whatever appropriate agency) decided that lower levels of radon could be detected, and it adjusted down the limit so that my house was in violation. My house didn't become more dangerous, the limit just became lower.

Could the same thing be true with our XPAP machines? I'm thinking mainly in terms of the emission issue. Obviously, it would seem inhaling bits of foam would be bad no matter what the standards are.