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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-13-2021, 05:10 PM)Glen e Wrote: It really is amazing how no one has contacted everyone that uses a Phillips about the recall. But there is one way that you can spread the word passively… I frequent about six or eight forums for various hobbies: cars , aquariums, auto detailing etc. and I changed my signature to the following:

Glen
Using a Phillips CPAP machine? Stop/recall/poss cancer

As of this morning,  I’ve had 25 people write me through direct message on the various forums and thank me profusely because they didn’t know a damn thing about it. I send them the link to this thread.

 BRAVO!

Thanks
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-13-2021, 03:55 PM)mrmagloo Wrote: The alternative would strangle the life out of innovation and business.  People have to think this through.

I disagree, the alternative would strangle the life out of innovation and business for companies that don't give a rats a$$ about their customers' well being, the law, or just doing things right. So be it. In Philip's case, they didn't give a rats a$$ about their customers' health while profiting handsomely selling a device intended to improve someone's health. Oh the irony. 

Someone, a real person or group of people made the conscious decision to use the non-bio-compatible (probably less expensive) foam material in the air circuit. Then another group of people prepared a fraudulent regulatory filing certifying that they had performed a bio-compatibility material analysis. Then another group of people sat back and did nothing for years while the complaints and returns rolled in. Then another group of quality system people turned their backs on their customers and the law. This recall isn't due to a simple single act of fraudulent stupidity, this is a coordinated series of criminal co-conspirators behaving like evil morons who apparently thought they would never get caught. If there is any justice left in this country one of the gazillion lawsuits hitting Philips will dig into the details and unmask the fraudsters and drive Philips/Respironics into the ground. Maybe they should just stick to light bulbs and sh1tty television sets. It's really hard to injure someone with a light-bulb. 

I would like to believe there are plenty of companies in business that are able to innovate and grow while following the federal laws of the United States of America and caring about people. OK maybe not Philips, Boeing, Purdue Pharma, or Philip Morris, but most companies realize that injuring or killing your customers is bad for business. If the USA really believed and trusted in capitalism we would let the weak, inept, and illegally operating companies die a quick death so the good ones can rise to the top for the betterment of society. Unfortunately, propping up loser companies managed by degenerates has become the way.   

Oh-jeez
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I think you missed my point, with that sentence. Of course, the manufacturers should be held fully accountable, and the regulations have plenty of teeth to ensure that. However, like I said, if you pay careful attention to how many of these play out, the frigging politics almost always eventually get in the way. Seldom do you see any personal responsibility even in the most egregious cases.

The alternative alluded to is a scenario where every single new product and innovation had to pass a battery of tests to prove it's performance, durability, safety, and suitability for the intended purpose prior to approval. Essentially requiring the FDA to get so involved that they in turn incur responsibility for approvals as the earlier poster was trying to suggest. We simply would never have the bandwidth, nor would it ever be appropriate to stifle business, or bog down the FDA in that manner. 

Clearly you understand that this is a trust system. I totally agree that corporations and individuals that break the laws, and by that virtue, the trust, should be held totally accountable, and Philips should certainly get no passes here.  I totally agree.  I am an effected user with a 10 month old DS flapping in the wind, and a lifelong Respironics/Philips customer, and you better believe I'm P*ssed. However, that doesn't give me the urge to start irrationally blaming others that should not rightfully be scrutinized.  The fault is with Philips, 100%.  Blaming the FDA in this case is absurd at this point.  Enough said.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Recalls

Two of the 18 Philips products recalled in June were also recalled earlier:

Mar-06-2014      Philips Respironics Trilogy 100; Trilogy 200; Ventilators

Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. 

I guess no one bothered to check out the foam.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Class Action Lawsuit

Filed 07/01/2021

Complaint-Filed-version.pdf (lfsblaw.com)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Glen, thank for the helpful idea about letting people know. I'll do something similar at the forums I visit.
====
Am caring for nonagenarian parents:  one uses a ResMed Airsense 11, and the other a ResMed Astral 150, full face masks, oxygen, humidifiers, modems.

Anyone else caring for very elderly loved ones?
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I must be in the minority, my DME called me mid July.
Normally Im pretty proactive DIY on things, I guess with the CPAP stuff I just assumed "no worries" and didnt follow any news about it at all until that point.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-13-2021, 08:47 PM)DaveCar Wrote: I must be in the minority, my DME called me mid July.

I met with my DME's RT on June 28th to work on some mask fit problems. This is a little 3-office operation, and I work with the smallest of the three offices. The RT told me that 1) She "hates Respironics because they don't listen." 2) She's only dispensed 38 of the recalled machines because she only dispenses a Respironics if the doctor specifies it on the prescription and refuses to change the prescription when she calls and asks. 3) She had a pile of A10's for her 38 patients, and was going to be calling them to convince them to replace their machines. 4) The other two offices are bigger so they had about 80 each, but they hate Respironics, too. 5) She's been in the biz long enough that that she doesn't call it Philips Respironics. 6) And all three RTs are saying "told you so."

Yeah, the DMEs and the VA and the big hospital systems and the insurance companies are PR's customers. And PR has just made the people at those companies spend huge amounts of time and money that they won't ever get paid for. So when you say "they P*ssed us off be we don't matter we aren't the customers" you have a point. But the point is that the customers are even more P*ssed off than we are!
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"The RT told me that 1) She "hates Respironics because they don't listen."

Companies who don't listen to customers also tend not to listen to suppliers.

It becomes obvious that Philips doesn't listen to suppliers when you look up the polyester urethane used by Philips and the polyether urethane which is used in some ResMed models. You can find numerous links posted by plastics and foam suppliers comparing these urethanes.

Both materials are well known. The problem polyester urethane has with hydrolysis is very well known and mentioned prominently. Suppliers are very clear that polyester urethane should not be used in applications where exposure to water or high humidity is a possibility.

Polyester urethane is superior for vibration dampening.
Polyether urethane resists molds, fungi and moisture better.

Suppliers offer both materials, and their focus at these pages is to help you decide which is best for your application. Cost isn't mentioned very often, probably because the difference is not significant.

However, I stumbled across this: "The polyesters are more expensive and susceptible to deterioration in damp or wet conditions."
https://tombrowninc.com/blog/understandi...ane-foams/

It is hard to understand why Philips chose polyester urethane foam. The decision does not appear to have been influenced by cost. If cost was the consideration, then the logical decision would have been to omit the foam altogether. We know from many users who removed foam from System One and DreamStation machines that the change in sound is very slight and not objectionable.

Philips could have made the correct choice by doing a few hours of research online and thinking about all the potential environmental conditions that would apply to their machines. I don't think that it is unfair for us to expect xPAP suppliers to listen and do their homework during the r&d process.

What's that smell? Is it negligence? Huh
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
For those thread members that might find this of any interest;

ADVISORY COMMITTEE MEETING

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. 

October 6, 2021: Patient Engagement Advisory Committee Meeting Announcement - 10/06/2021 - 10/06/2021 | FDA
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