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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"For any Canadians who wish to discuss this issue"

Thank you for the email addys.  I emailed support and cc'd the prez and myself as part of my "paper trail" now.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The Wall Street Journal

Sleep Apnea Sufferers Scramble After Philips Recall of Critical Machine

[color=var(--color-nickel)]Prices soar for alternate devices and some users try a do-it-yourself fix after machines are found to emit potentially harmful gases, particles[/color]


[color=var(--color-nickel)]This is the link, but you need to be a subscriber to read the full article;[/color]

[color=var(--color-nickel)]Sleep Apnea Sufferers Scramble After Philips Recall of Critical Machine - WSJ[/color]
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Phillips CPAP recall impacting millions
By
 Brian Armstrong
 -

August 6, 2021


CHATTANOOGA, Tennessee (WDEF)- Philips is recalling millions of CPAP machines used to treat sleep apnea.

“I’ve been in Chattanooga for 27 years. I have not experienced anything like this,” said Sleep Medical Specialist Dr. Anuj Chandra.

Back in June, Philips issued a recall for specifically affected ventilation and sleep apnea devices



“The noise abatement foam which is inside the machine and for unknown reasons is Disintegrating into the hose and people can actually inhale it,” said Chandra.

Now people who rely on CPAP to stay alive are put in a tough spot.



“For people with certain heart conditions, previous strokes, neurological conditions their risk for stopping are much more than a slight risk of having this form come through the house. Then for other people who have mild or sleep apnea, the risk of the foam outweighs the benefits of using it,” said Chandra.



The FDA has identified it as a Class I recall, the most serious type. He said don’t stop using your CPAP without contacting your doctor.

“Please be patient, it’s not the doctors or the medical equipment company that you got the machine from, their fault. Phillips is responsible for this. They do take ownership,” said Chandra.

He said normally doctors would say stop using the recalled machine and get another one but that’s not always possible now due to a backup in the supply chain.


“A lot of these machines are manufactured in China. So we really need to think of bringing these really important manufacturing concerns back in the US so we never have to face this again,” said Chandra.
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WSJ: "Sleep Apnea Sufferers Scramble After Philips Recall of Critical Machine"
(08-16-2021, 09:39 AM)btreger Wrote: << above WSJ article >>
The reporter did a good job on that recent WSJ article, compared the others who have done follow-up articles.  We're now well into the follow-up news phase which should cover Philips actions so far, the reaction of the related parties (sleep centers, hospitals, insurance companies, etc.), the impact on the industry (competitors, pricing, newly diagnosed, etc.); and, most importantly, the real impact on the recalled device user community.

Quote:
[WSJ]  Since the recall was announced, doctors have been inundated with calls from worried patients. Prices for machines made by Philips’ main competitor, ResMed Inc., have shot up and the devices are becoming more difficult to get. Some patients, feeling ping-ponged between Philips, medical-device suppliers, doctors and insurers, are taking matters into their own hands, either by removing the foam themselves or bypassing insurance to buy new or used machines out of pocket."

When Mr. Horton, a 30-year-old paramedic from Glen Allen, Va., called his medical-device supplier for an alternative, he was told none was available. For now, he is continuing to use the Philips machine.“Every night, I feel like I’m having to pick between cancerous inhalants and my oxygen saturation dropping,” he said.

The reporter did a call-out to the community on the largest general chat board, but it didn't get the significant response that it deserved.  After all, there are possibly 3-4M affected users.  It's great that some have referenced this thread with their news media (and other) communications.

The article did well by mentioning three types of user responses:
  • no change in usage ("can't be that bad")
  • de-foamers (can't/won't go out and spend another $$$)
  • purchased a replacement system, or on-order
These after-story news articles will do a variety of things:
  • describe the general state of the industry
  • point out the frustration of the affected users
  • introduce the recall to those device users and non-users who don't know about it yet
  • put a lot more attention on the Philips company
  • appeal to a reader's sense of "fairness" and "corporate responsibility"
We're mid-August now, and Philips has not yet received their FDA approval by their initial estimate.  That was very predicable.  It's peak vacation season, they had 200+ FDA foam applications, and the FDA might not want to "rush it" given the focus is on them too these days.  September will likely be a time where many issues related to the recall will come to the surface - FDA approvals, legal class-actions, Philips follow-up communications, a clearer picture of the real state of the PAP device production from all companies, etc.  

A big "thank you" to all those who have given very helpful guidance to all other affected device owners.  It's so gratifying to know that we don't have to merely accept all that has been laid out for us.  There is so much more that we can do, individually and as a community.  I hope that we all continue to direct other recalled device owners to ApneaBoard and this specific thread.  At the very least, it will give other recalled device owners a greater feeling that they're not alone, and they're not merely at the mercy of Philips - or even their DME.
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PHILIPS' COMMENTS ON BACTERIA FILTERS
There's a document at Philips' site that may, or may not, have been previously referenced.  Strangely, and regrettably, Philips hasn't put a publishing date on the document - almost to suggest that it was released at the very beginning of the recall announcement, or perhaps Philips wishes to give that impression.  (If this is not "new news", please let me know and I'll remove it.)



"Supplemental clinical information for physicians and providers for specific CPAP, Bi-Level PAP, and mechanical ventilator devices with the use of bacteria filters"

This document is intended to provide an overview of particulate characterization and bacteria filter performance for CPAP devices.

https://www.philips.com/c-dam/b2bhc/mast...cument.pdf

Bacteria Filters for CPAP

Due to an influx of questions, additional information is being provided about the use of bacteria filters with CPAP/BiLevel devices. According to FDA regulation 868.5260, bacteria filters are medical devices that are intended to remove microbiological and particulate matter from the gases in the breathing circuit. Philips does not recommend using bacteria filters outside of their normal intended use.

Therefore, these bacteria filters should not be used on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical emission or particulate matter for the following reasons:
  • Bacteria filters do not provide protection from the chemical emissions resulting from manufacturing or continued foam degradation. Furthermore, possible gas emission of the degraded foam has not been fully characterized yet throughout the life of the CPAP/BiLevel device.
  • In-line bacteria filters are not intended to be used under the current affected CPAP/BiLevel devices use cases.
  • Federal law (USA) restricts bacterial filters for sale under the order of a physician.
  • In-line bacteria filters are specified to be used where they can be monitored by a medical professional.
  • Bacteria filters need to be replaced frequently as referenced in the bacteria filter manuals, or as deemed necessary upon inspection by a medical professional.


***Note to Gideon, the creator of the terrific Philips Recall Wiki:  
The above referenced Philips document might possibly be a new addition for the Wiki.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Long time listener, first time caller here! 

My DS1 was new 2.5 years ago with no miles on the engine. 

I know there’s been some speculation about how the replacement will happen. This may have been posted but, well, I didn’t want to go through 116 pages to find out.

Just got off the phone with my DME (Kaiser Perm in Portland, OR). Dude I spoke with said the latest update they have is that machines are to start rolling out in 2-3 months and that it won’t be a refurbishing then replacement scenario, but a full on exchange for a new machine. 

Of course all their stock was affected devices and no, they don’t have replacement machines of other brands that aren’t affected, and yes, I’m SOL until Philips graces me with a new machine.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
How will Philips prove that the new machines do not have dangerous foam?
====
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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PHILIPS' REPLACEMENT PRODUCTION SCHEDULE
(08-16-2021, 02:15 PM)FartyMcgee Wrote: << above >>

Thanks so much for your update.  We appreciate any updated information that DMEs may receive directly from Philips.  

The DME's message might be painting a rather optimistic picture of what's coming.  Of course, who can blame them for that, as they themselves are in "crisis control" as a result of their frequent communications from affected clients.

Philips' early message of replacement shipments at peak capacity (in November, I think they said) came with conditions:  "supply chain challenges" for components, FDA approvals mid-August, etc.  Other device suppliers are also fighting for similar component productions, amongst an ongoing CV/CV-recovery environment.  

The largest challenge might be the fact that Philips needs to replace a very large number of devices.  If I'm not mistaken, someone previously mentioned that 1/3 of the 3-4M devices will be replacements instead of "fixes".  Philips said they would be producing about 80,000/week and needing to replace about 1M devices - their best-case scenario - and that's starting at their peak-production month.

Therefore, it could be awhile before candidates for "replacements" actually get their new replacement.  How will Philips prioritize replacements amongst the entire community of hospitals, sleep labs, country medical agencies (e.g. U.S. VA), end-users, country, SoClean use (indicated in registration) and recall registration date?  We can probably assume that Philips will apportion a small percentage of production to each category so that all faulty device owners "feel" the process has started for their category.
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RE: PHILIPS' COMMENTS ON BACTERIA FILTERS
(08-16-2021, 01:42 PM)WakeUpTime Wrote: There's a document at Philips' site that may, or may not, have been previously referenced.  Strangely, and regrettably, Philips hasn't put a publishing date on the document - almost to suggest that it was released at the very beginning of the recall announcement, or perhaps Philips wishes to give that impression.  (If this is not "new news", please let me know and I'll remove it.)


The link to the article shows up on the AASM website. The link says (August).
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RE: PHILIPS' COMMENTS ON BACTERIA FILTERS
(08-16-2021, 01:42 PM)WakeUpTime Wrote: There's a document at Philips' site that may, or may not, have been previously referenced.  Strangely, and regrettably, Philips hasn't put a publishing date on the document - almost to suggest that it was released at the very beginning of the recall announcement, or perhaps Philips wishes to give that impression.  (If this is not "new news", please let me know and I'll remove it.)

FWIW, The create date on that document is 8/2/2021  3:28PM
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