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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-30-2021
(08-30-2021, 01:28 PM)Mustang 85 Wrote: As a physician, I can tell you with certainty that not every person diagnosed with OSA is using PAP therapy. A lot of people just won't adapt to wearing that mask at night. So PR estimate of 3-4 million devices in the US is probably fairly accurate, if not a little high.
Well, I guess I would agree with this last paragraph, I have a relative who falls into this category, and stopped using his machine after one month. We probably all know of someone who fits that conclusion.
On the numbers side, we would both have to admit that there are many sources of numbers that anyone could find if they looked hard enough. I would not swear that the numbers I presented were 100% accurate, and I said so. I think you should do the same.
Sleep Apnea Statistics
If you or a loved one have been diagnosed with obstructive sleep apnea, or suspect that you may have it, these statistics may spark your interest:
It’s estimated that one in 15 adults in the United States has obstructive sleep apnea, which equals 18 million people. Approximately 80% of these people are undiagnosed. Although men are at a higher risk of sleep apnea than women, both sexes can suffer from this disorder. Children can also have sleep apnea, although at a lower rate of prevalence. Approximately 2 percent of children suffer from sleep apnea
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-30-2021
(08-30-2021, 02:16 PM)btreger Wrote: Well, I guess I would agree with this last paragraph, I have a relative who falls into this category, and stopped using his machine after one month. We probably all know of someone who fits that conclusion.
On the numbers side, we would both have to admit that there are many sources of numbers that anyone could find if they looked hard enough. I would not swear that the numbers I presented were 100% accurate, and I said so. I think you should do the same.
Sleep Apnea Statistics
If you or a loved one have been diagnosed with obstructive sleep apnea, or suspect that you may have it, these statistics may spark your interest:
It’s estimated that one in 15 adults in the United States has obstructive sleep apnea, which equals 18 million people. Approximately 80% of these people are undiagnosed. Although men are at a higher risk of sleep apnea than women, both sexes can suffer from this disorder. Children can also have sleep apnea, although at a lower rate of prevalence. Approximately 2 percent of children suffer from sleep apnea
I have rerun my numbers and you are correct, I did make a mistake...............
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - DaveCar - 08-30-2021
"labs that can test a Dreamstation to determine"
A lab could test what is coming out of the hose of a dreamstation, but you would have to tell them what to look for. Generally speaking they dont test for "everything thats bad", as that would involve a huge set of tests ($$$).
There is a Philips document that says what they found during their own lab tests, which you could have a third party lab duplicate, but how do we know that Philips didnt accidentally forget to look for some PE-PUR byproduct (assuming the foam is 100% PE-PUR in the first place).
And thats also presuming that your Dreamstation is currently degrading, maybe your foam isnt breaking up yet ?
I'm on a class-action out of Toronto and they did say that they have examples of foam shedding but didnt advise me if I should retain my unit (shedding) as personal damage evidence or not.
Edit: Found it. They tested a unit for 168 hours at 35c to measure products. 168 hours would be the equivalent to one month of sleeping. The did find some initial offgassing of two chemicals which dissipated after a short while (ah that new foam smell). Imho their test was lame. These things are breaking down the foam after some number of months (the shortest period with found foam that Ive seen stated was 6 months. Mine was 2.3 years old.) A test of a "used" (but less than 5 years old, the recommended replacement timeline ) machine would be far more indicative.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Nella - 08-30-2021
Interesting. I'm still at the stage of generally being curious and even finding a lab that would do this kind of testing. The specifics would need to be determined, of course.
I'm curious about your class action. I spoke with just a few US law firms and they seem to be focusing on individual cases at this point, saying it's all still new. Is your class action focusing on people having been diagnosed with particular conditions directly related to using the CPAP? Or is it focused on the general awfulness of how Philips has been handling it and the danger it puts people in? Or a combination? Still deciding if I want to take legal action and have asked one firm if they do this kind of testing I described.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-31-2021
Update to Post #1333
PHILIPS RECALL: SENATOR PUSHES FOR ANSWERS
News
HME News Staff
Updated 9:09 AM CDT, Mon August 30, 2021
WASHINGTON – Sen. Richard Blumenthal, D-Conn., sent a three-page letter to Vitor Rocha, the CEO of Philips North America, on Aug. 24, asking him to answer seven questions, including, when does Philips expect to have repaired or replaced all impacted devices?
Blumenthal’s other questions:
How many devices have been impacted by this recall, and how many patients are believed to have been impacted by this recall?
What percentage of impacted patients have used the Philips established registration process to register a recalled device?
Please also provide the total number of impacted patients who have registered.
How has Philips reached out to affected patients to alert them to this problem and how is Philips continuing to ensure all affected patients learn of this problem?
What percentage of impacted patients who have registered their device has received a response from Philips regarding their recalled device?
Please also provide the total number of impacted patients who have received any response.
What percentage of impacted patients have had their recalled device repaired or replaced by Philips’ “comprehensive repair and replacement program”?
Please also provide the total number of impacted patients who have had the issue completely resolved through replacement or repair.
When does Philips expect to submit a mitigation plan to FDA for authorization to permanently resolve this problem?
If it has done so, has it provided FDA with sufficient evidence to show that the mitigation plan eliminates the product defect and the product is now safe and effective for use?
Blumenthal asks for answers to his questions by Sept. 7.
Philips recall: Senator pushes for answers | HME News
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - StratCat48 - 08-31-2021
Why do I have the feeling that getting the government involved in the recall can only worsen an already bad situation
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - oldgreenhead - 08-31-2021
(08-31-2021, 01:29 PM)StratCat48 Wrote: Why do I have the feeling that getting the government involved in the recall can only worsen an already bad situation
StratCat48,
Certainly i see more ineffectiveness in government these days that I would like. However, in this case I feel that we need as much weight on the side of the consumer as can be mustered. Philips has made it clear to many of us that their response will, at the least be slow and plodding. Those who cannot afford to cough up the cash for a new ResMed machine have already been left with grave concerns about their health and much uncertainty about Philips commitment to a real solution.
Absent the FDA and people like Blumenthal, we are left to lawsuits and the courts. That answer, if it is one, will take years.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SleepyCPAP - 09-01-2021
Breaking news: Philips gets go ahead from FDA to start the repair/replace process this month
https://www.reuters.com/article/philips-recall/philips-to-start-replacing-millions-of-respiratory-devices-idUSL1N2Q30DS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-01-2021
LAW.COM
Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Koninklijke Philips N.V.
Aug 31, 2021 2:34 PM ET
Legal Newswire POWERED BY LAW.COM
Bernstein Liebhard, a nationally acclaimed investor rights law firm, announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Koninklijke Philips N.V. from February 25, 2020, through June 11, 2021 (the "Class Period"). The lawsuit filed in the United States District Court for the Eastern District of New York alleges violations of the Securities Act of 1934.
The complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) Philips had deficient product manufacturing controls or procedures; (2) as a result, the Company's Bi-Level PAP and CPAP devices and mechanical ventilators were manufactured using hazardous materials; (3) accordingly, the Company's sales revenues from these products were unsustainable; (4) the foregoing also subjected the Company to a substantial risk of a product recall, as well as potential legal and/or regulatory action; and (5) as a result, the Company's public statements were materially false and misleading at all relevant times.
Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Koninklijke Philips N.V.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-01-2021
yahoo finance
Philips starts to repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification*
Philips International B.V.
Wed, September 1, 2021, 2:00 AM
Amsterdam, the Netherlands – Royal Philips today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that were issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of the replacement of the PE-PUR sound abatement foam with new material. Philips anticipates reworking to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US
Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification* (yahoo.com)