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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"A Recall Of Philips Respiratory Devices Has Left Users Stranded"

"Over a month after the recall, people who rely on ventilators, CPAPs, and BiPaPs are unsure what to do"

"Yet over a month after the recall, people who rely on these devices to breathe are still scrambling to figure out what to do. Philips recommends that people register their devices and follow the advice of their doctors when deciding whether to continue using them. But most people who use these devices can’t go without them, even temporarily. Just one night without a BiPAP is detrimental to their health, and other people need their ventilators around the clock.

"The existence of the recall has been poorly communicated. Some people found out about it through a Facebook group for people with neuromuscular disabilities, not through their doctor or Philips.  Several people have described a frustrating loop of conversations with doctors, less than sympathetic medical equipment suppliers, and insurers, while often being unable to reach Philips through its hotline. “Many people are getting the runaround while a few were able to get a replacement machine from another manufacturer immediately".

"The slow and convoluted process hasn’t been enough. “Disabled people have always been considered disposable by society, and this is another ugly example of it.” Some people are calling on Philips to be more transparent about its plans for repairs and replacements. The company should pay for comparable machines from other manufacturers, reimburse people who purchased additional equipment out of pocket, and staff its phone line with people who have thorough information and resources".

"But even that wouldn’t address the larger problems at play. A small number of companies produce the majority of durable medical equipment like ventilators, and patients have little choice which machines they end up with based on their insurance. When one of those companies announces its products have dangerous defects, there’s not much of a contingency plan for the people who rely on them".

From THE VERGE

Over a month after the recall, people who rely on ventilators, CPAPs, and BiPAPs are unsure what to doOver a month after the recall, people who rely on ventilators, CPAPs, and BiPAPs are unsure what to do
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
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RE: Recall of Philips CPAPs
@Ockrocket 

I actually got my System One end of 2016 or 2017. And it actually stopped working. I've been borrowing my dad's for now, I will be calling them and see what they say.
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NEWS ARTICLE
Thanks btreger for all your media efforts, and being the 1,000th post in 100+ page thread, that will eventually surely be in the top 10 all-time thread views.  By Philips being 1/2 the industry, and now dramatically affecting the other 1/2 of the industry, how could it not.  And, in practical terms, the Philips Recall hasn't actually begun.  Philips is still waiting for their 200+ applications for foam replacements to be approved by the FDA.

Your Verge article reference is very good, as it takes the recalled users perspective.  It's good to see the media finally moving on to addressing the real impact on recalled device users.  When the Philips Recall was first announced, they didn't quite understand the real implications for end-users.  They're starting to now, perhaps as a result of some of your efforts.

From that Verge article, one woman would be a great spokesperson for all recalled device users:

Quote:
She and others are calling on Philips to be more transparent about its plans for repairs and replacements.
She says the company should pay for comparable machines from other manufacturers,
reimburse people who purchased additional equipment out of pocket,
and staff its phone line with people who have thorough information and resources.

[Ref: A recall of Philips respiratory devices has left users stranded - The Verge]

Perhaps it is Philips best interests to have the recall gradually roll out over 12-18 months.  They've already taken the two 250 Million Euro charges over two quarters so not to affect their quarterly earnings too dramatically.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Comments Concerning The FDA:


For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

A federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly training.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct, and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”


The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.


When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"There are real differences between a warning label on a drug and Philips’ recall language. The warning label is to be read and considered by a patient MAKING A CHOICE that has not yet been made. The Philips recall letter is entirely different—information that was never given to the patient and that is now TOO LATE to be helpful; it is a statement of what harm has been done and it expresses the degree to which the patient was misinformed from the start of treatment."

That's true of every recall that's ever been issued. Tyson sends out bad chicken, people eat it, there's a recall. People are made sick. Etc.

I think this is just part of the definition of a recall.

anyway, again, the likelihood (according to the Brits and Canadians) is that few will turn out to have been affected. Again, PR's statement details what MAY occur--as in a drug allergy warning--not what has or will occur.

PR didn't know the foam could degrade like it has. They couldn't warn us from beforehand because they didn't know. That's also how recalls work. a problem comes to light that the manufacturer didn't know about; there's a recall. Boeing for example.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-05-2021, 03:35 PM)hegel Wrote: anyway, again, the likelihood (according to the Brits and Canadians) is that few will turn out to have been affected

Incredible that you're still quoting those documents implying that the Brits and Canadians have done their own thorough investigations on Philips recalled products.  Nothing could be further from the truth.  Those papers are only going on the minimalist end-user complaint numbers that Philips received, and disclosed, prior to the recall.  It's important to note, when referencing those documents, that their conclusions are completely based on the information provided by the manufacturer.  

Similarly, a report that advises on health concerns related to smoking, that is merely based on data provided from Philip Morris, wouldn't be considered extremely valuable.

Philips is promoting that this complaint number is extremely small compared to its entire installed base of end-users.  Philips is correct in that the faulty-foam has not caused immediate harm or death in most users.  (The same could be said about smoking.)  Furthermore, if there were reports of large flakes of foam particles appearing in masks, it goes without saying that there are small particles that have been ingested by recalled device users that went unnoticed.  That doesn't imply that it's insignificant - especially over a longer period of time.

Now that people know what the health implications are, as a result of the defective foam with cancer-causing components, people are making their reports directly to the FDA (and other agencies in the U.S. and elsewhere).

You're welcome of course to use those papers in your PAP decisions; though you haven't been impacted in any way by the Philips recall.  Yet you continue to minimalize the concerns of affected recall device users.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
As WakeUpTime says:  "Yet you continue to minimalize the concerns of affected recall device users."

Exactly.  Oh-jeez  Leave us alone.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
" Leave us alone."


"Us"...? only people who agree with you allowed? Please respond to the the points I've made, rather than simply tell me to get lost (again--for the fourth time). "Get lost" is not a reasonable response to reasoned arguments.

You wish to be left with your fear and misery. You and Wakeup and others feel that you're doomed and tell that to millions of machine users. Several government health agencies with access to legitimate evidence based tests disagree. Please re read my posts. Frankly, I think you're all pushing fears that aren't justified and many who read your posts will freak out unnecessarily. That/'s why I don't get lost, but it's wearying and I may, out of exhaustion.

I don't use a recalled PR machine. I've written that I would replace mine if I did, and if I could--or at a minimum use a filter to suss out the state of the foam in my machine.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
It's frustrating waiting for answers.
Sleepless No More
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