[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[btreger]

APNEA BOARD FORUMS 

Unfortunately, we have a few members of this thread who feel it is their job and theirs alone to tell everyone else what is true or not true. What is false or not false. They believe in censorship, where they alone have all the correct information and no one else can be trusted to provide important information, they may not agree with.

I believe the members of this thread are smart people, if they read something that doesn't feel right or is way off base from already known facts you will dig deeper for the truth and then make your own decisions. You do not want someone telling you what to believe or what to think. 

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INFORMATION POSTED ON THE APNEA BOARD WEBSITE AND FORUMS ARE PERSONAL OPINIONS ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

[Crimson Nape]

Keep this thread on topic!

[WakeUpTime]

CPAP Recall Leaving Patients Using Potentially Dangerous Devices
CBS NEWS 4 - December 24, 2021 - SUSAN EL KHOURY, INVESTIGATIVE REPORTER
https://www.kmov.com/news/cpap-recall-le...ffb79.html

Millions of people who struggle to breathe while they sleep are facing a tough choice amid a recall where some are being told to keep using CPAP machines that could potentially put their health at risk.

• Philips Started Getting Complaints in 2015
  
• Company Executives Were Made Aware in January 2020
  
• Waited More Than a Year to Take Corrective Action
  

ST. LOUIS (KMOV.com) -- Millions of people who struggle to breathe while they sleep are facing a tough choice amid a recall where some are being told to keep using CPAP machines that could potentially put their health at risk.  In June, Philips recalled certain CPAP devices. The company didn't start replacing the machines until August.

The recall centers on foam used inside the machines to reduce noise and vibration. According to Philips the foam can "degrade" and some people may inhale chemicals that can cause cancer.

"Am I going to get some kind of disease from it? Could I get cancer? I don't know," said Patrick Quinn, who's been using a CPAP since 2014. "I shouldn't have to lay my head down on the pillow every night and wonder about that."  Quinn said he needs the machine to sleep at night, so until he can get a new one, he can't stop using his recalled device.

"I have epilepsy and if I don't get six, seven, eight hours of sleep a night that can trigger seizures," Quinn said.  While the recall is now months old, Quinn said he just found out from a friend.  "I was just dumbfounded that I would find out that way rather than Philips calling me, emailing me," Quinn added. "It infuriates me."

In November an investigation by the Food and Drug Administration (FDA) discovered Philips started getting complaints about the issue in 2015. FDA investigators also found that company executives were made aware of the issue in January 2020, but waited more than a year to take "corrective actions."  

Doctors and nurses who are now trying to help their patients are playing catch up.  "For us there was a lot of uncertainty because we did not have a lot of information at the time the recall was announced," said Loretta Colvin, a nurse practitioner at SSM Health who specializes in sleep apnea. "Right now we don't know much about the potential risk of continued use of the machines because it's just a new recall."  Colvin said initially the guidance from Philips was to stop using the affected devices. She said that changed in recent weeks and Philips is now telling people to contact their health care provider to determine what's best for them.

Colvin said in some cases people can stop using the devices, but for others the risk of not having it is too severe.  "What we're going to advise them is going to depend on their severity of sleep apnea," Colvin said. "We worry about serious health problems like heart failure, atrial fibrillation, strokes, heart attacks."  Colvin is seeing patients struggle to get new machines as the combination of the recall and pandemic supply chain issues cause shortages.  "It's beyond our control," Colvin said. "We're hoping for a solution but the pandemic is going to limit the options."

That's something Quinn already learned as he now faces a months long wait for a new machine.  "They're telling me that it could be three to six months to get a new CPAP machine," Quinn said.  There are other companies that make CPAP machines. However, many people affected by the recall rely on insurance to cover the cost of their machine and that limits how often they can get a new one.  Out of pocket costs for a CPAP can run upwards of $1,000.  "Rock, hard, place, I'm in the middle, that's how I feel," Quinn said. "I want to see everyone get a newer version, one that is FDA trusted and approved."

Philips said it expects to finish replacing all of the affected CPAP machines by September 2022.

News Video

[WakeUpTime]

The FDA, or the judge in the class action lawsuit, needs to demand that Philips continually update the percentage of all registered Recall devices that have received a fix/replacement - by country.  I'd estimate that number at the moment, after many months, to be very small.  By listing each country, it will also demonstrate how some countries, through their stronger consumer protection laws, have received significantly better results from Philips (e.g. Australia, etc.).

[EddieR]

When I first heard about the recall earlier this year (on this forum) I talked to my DME - Lincare - about getting a replacement. They hadn't heard about the recall, so were unprepared. I gave them a week to "find out", then called them again - they were still unprepared but were "unofficially" notified of the recall. My insurance company - Tricare - was amazingly unhelpful, they wouldn't purchase a new/different machine for me since it hasn't been 5 years yet. I continued using my 3yr old machine ( I never used Soclean or any other ozone cleaner so I wasn't that worried) until I could find an affordable and un- or lightly- used Airsense S10.
On a side note, Lincare has called me faithfully EVERY month to reorder supplies etc for my Dreamstation...until July -- I haven't received a single call from them since! LOL How's that for patient care? So much for getting a replacement machine from them!
I didn't get notified by Phillips until December 2021. By then I had found a 1600hr Airsense for $400 in the local area. Bought it, cleaned it, ordered new everything that I would need for it from Amazon or Ebay, programmed it for my needs, and have used it for two weeks now. It's smaller and quieter than the Dreamstation, seems to be working OK for my treatment so I'm happy.

My question is, has anyone received their replacement from Phillips and then turned around and sold it new in package? How much could I expect to get for it?

[Moriarty]

…How much could I expect to get for it?

I’ve wondered the same thing… then thought ‘if I don’t want to use it because I have lost faith in Philips how could I sell it in good conscience…?’  
 My answer to myself was that I would probably keep it as a spare…

[WakeUpTime]

Philips had stated early on that they're not going to be selling DS2s for a long time, producing them all for some time to come as DS1 replacements.  Eventually, there will be a very large number of unused (or very lightly used) DS2s out there that are (to use the Philips CEO's term) "shelved".  I wonder if DS2 replacements are pre-registered to their recipients.  Either way, DS2 owners and equipment resellers will likely be exploring all profitable opportunities.  Most will also know not to wait too long as the DS2 resale market will likely increase significantly in the months to come.

Philips has a very good marketing department.  I wouldn't be surprised if they announce a DS3 in 2023 after the massive Recall program is completed.  A DS3, with a new design and/or feature set, wouldn't have to compete with the large quantity of free unutilized DS2s that flooded the market.  ResMed may face price-pressures down the road as a result of large quantities of new or lightly-used DS2 available for resale.  Meanwhile, Philips will use those numbers to demonstrate it is still maintaining a near-50% market share, although many of those DS2 units may not be 'active'.  In the mean time, as a result of supply chain issues, demand continues to outpace supply.

[StratCat48]

A couple DS2's $799 to $1100 both claiming to be new in the box and unused on a site of private sales I frequent for deals. I somehow doubt the manufacturers warranty would extend to the buyer if not sold through an authorized seller/dealer. Not sure how transfer of the original owners serial number would work to enable use with Dream Mapper if that was to be used for monitoring. The Dream Mapper card reader software does not currently work with DS2 data.
If it were me, I'd keep it as a spare. I have no issues with my DS2 and it works well.

[BobbieM]

All companies pay for outside, independent (as in not part of the company) labs to for things. And no lab worth it's name lets the company that hired them influence how the testing is done or reported.

I am your average schmo with only high school background in science and tech stuff. But I do believe that it is very difficult for a person to be objective if his income depends on him being biased in favour of whoever provides that income. 

Surely you all still remember Enron and how investment banks and ratings agencies raved about the performance of the company based on numbers signed off year by Arthur Andersen, one of the global big five auditors. Numerous papers have since been written on the impossibility of auditor independence as long as the auditor is chosen and paid for by the company they audit. 

People do not live off thin air. Laboratories have overheads, staff to pay, and presumably exist to make a profit. They are not charities. To survive they are unlikely to make inane claims such as "foam degradation does not exist" but how far are they going to push the envelope in terms of looking for signs of intentional negligence. 

Companies should be made to pay for third parties such as auditors to check on facts but I cannot understand why the government allows them to pick that third party. If the Philips lab was chosen and appointed by the government, the results would have far more credibility. 

As for "no lab worth its name", I wonder how many of us even knows the name of the lab, where it is headquartered and fewer still would have gone through the track record of that lab and how rigorous its methodology is rated in the scientific community instead of peers which incidentally are not randomly chosen nor their negative views necessarily included.

[hegel]

So...you're implying that, by definition, nothing stated by PR or any manufacturer can be trusted. How about drug companies? No. How 'bout statements by the garage down the street that your brakes have been fixed? Again, no.

etc.

It's impossible to live like that. In fact, in the vast majority of cases, standards are followed. Of course there are exceptions! And nasty ones at that. so yes, caution and due diligence is required. But assuming that all hired scientists and researchers are bought off and simply publish what the manufacturers demand isn't true. That means that all people are base cheats willing to endanger the public in order to make money for themselves. they--we--are not. 

Cynicism has to be tempered by reality.