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

[WakeUpTime]

You and Wakeup and others feel that you're doomed and tell that to millions of machine users. 

Unfortunately that's an extremist inaccurate representation of user posts and will be reported as posting misleading information and making personal attacks - breaking forum rules.  It may be your ongoing attempt to de-rail this valuable thread, though I'm not exactly sure of your motivation for doing so.  As an analogy, that's like labeling coronavirus concerns as falsely saying they're promoting that everyone was going to die.  That's a strategy designed to negate people's concerns related to any or all known and possible harmful effects.

[Gideon]

I've got two words, directed at no one in particular.

Play Nice

[SuperSleeper]

I've got two words, directed at no one in particular.

Play Nice

Bears repeating.

People are getting close to personally attacking other forum members in this thread.  Concentrate on the issues, post your thoughts & opinions, but remember this particular forum rule:

Ad hominem attacks against forum members are prohibited.

DEFINITION of "Ad hominem":

Adjective.  (of an argument or reaction) directed against a person rather than the position they are maintaining.  (source)

On Apnea Board, ad hominem attacks against forum members are prohibited.  When participating in the forums, please discuss the concepts, ideas and topics themselves, rather than attacking a forum member's person or character.

[SingingSam]

"actually that's not clear at all. Which documentation are you referring to? You just mentioned in the same post that the Canadian govt. sees little risk; and the complaint rate is miniscule.

the idea that all foam in everyone's machine is and has been emitting a continuous stream of invisible cancerous particles is exactly NOT what's been documented. that's a frightening picture. Which credible source does it come from?"

Hegel wrote the above (Post 989) in response to me writing, "It is reasonably clear from available authoritative documentation that PE-PUR foam emits particles under the best of conditions." (Post 988)

Note that I wrote "reasonably clear", which means that foam particle emission is a clear reality to a reasonable person who is aware of all the pertinent facts provided by PR and other official sources. Here are some reasons why reasonable people have arrived at this conclusion.  

1. The recall is universal. Every machine in the class is recalled. No exceptions.
2. The recall is "based on available information" to quote Philips' notice. Philips is not in doubt. Their virtue-signaling "abundance of caution" has more to do with class lawsuits than with particles. They are certain that 100% of the machines emit particles when used and cleaned exactly as directed. Every device must be repaired or replaced.
3. There are no official notices or guidance documents stating unequivocally that if your xPAP has never been exposed to high temperature, high humidity or unapproved cleaning methods then you are not at risk from particles emitted by the foam. There's not even a hint that a user is perfectly safe under any circumstance - other than putting the recalled xPAP in the closet permanently.
4. The guidance is clear that excessive heat, high humidity and unauthorized cleaning methods make the foam degradation problem worse, not that they cause the foam degradation problem. They're saying that every recalled xPAP has a problem. They're saying that devices exposed to much heat, humidity or unapproved cleaning have an even worse problem. Their language is vague, but there is nothing vague about the fact that every recalled device puts its user at risk. This includes xPAP users who have resorted to off label use of an AB filter.
5. Nowhere is it stated that users who scrupulously follow the official directions have only a potential problem. Philips warns, "The absence of visible particles does not mean that foam breakdown has not already begun".
6. Philips warned that proper cleaning will not eliminate the risk of particles and VOCs. They wrote, "Note: while proper cleaning may help to identify presence of particles within the device, patients are still at risk of exposure to degraded sound abatement foam particles and VOCs". This means that after you thoroughly clean the xPAP, the foam will produce more particles and VOCs.  
7. Philips advises all users of affected xPAPs to discontinue use immediately. No exceptions. Consider that in light of official statements that off-gasses quickly cease to be a significant problem. If off-gasses aren't the driving issue, then what is the problem? What drove Philips to issue a costly blanket recall? What led the FDA to make it a Class 1 (the most serious class) recall? It is the particles.
 
If you have been using and maintaining as directed by Philips a recalled xPAP with PE-PUR foam, then it has been emitting PE-PUR foam particles, and you have been inhaling them. Even if you have installed an unauthorized AB filter. Accepting this fact is an important step toward correcting the problem. I am stating the above as a simple and unassailable facts. I've never said that the sky is falling or that we are doomed to get cancer or any other dreaded disease. It is inappropriate for anyone to attempt to put such words in my mouth.

Although the facts above are enough to satisfy many people, I've stopped short of answering the most important question of all. Namely, "Sam, how can I be 100% certain that my very own gently used and meticulously maintained PR DreamStation or System One is shedding particles that I will surely inhale deeply into my lungs because I can't block them all reliably with an AB filter?"

PR has already said why in writing, which I will document in 1 or 2 follow-up posts.

[hegel]

When Tyson issues a recall for a particular lot of lettuce, they recall the entire lot--even though not all of the lettuce is contaminated. When Toyota issues a recall on makes of their cars because a faulty airbag switch has been found in some, they recall all the cars--even if most have functioning switches. This is how recalls work.

I'm questioning if all recalled PR machines are emitting a continuous stream of invisible carcinogenic particles all the time. Has that been documented? Or is inference only? Again, it's a terrifying thought, if true. I think statements like this need to be evidence based. Otherwise, they only produce anxiety where it may not be warranted. There's enough legitimate worry about all this as it is.

It will most likely all come out in the wash eventually, and better guidance and info will hopefully follow soon, based on evidence from testing. Maybe it will turn out to be just that bad. But PR must have had to pass tests in order for these machines to be approved in the first place. The foam itself must have had to meet safety criteria. I'm reasonably certain any continuous stream of carcinogenic particles would have been detected by PR themselves before the release, or by the FDA or whatever agency is in charge of authorizing such medical grade machines.

[oldgreenhead]

I have been fortunate to obtain a Resmed Aircurve 10 ASV to replace my four year old Resperonics Dream Machine ASV.  Clearly demand is already through the roof and unfortunately, prices are following.  This process (including insurance company approval) required about 5 weeks.  I continued to use the Philips machine while I was waiting. What a Hobson's choice.  Clearly, Philips is offering no real help with this dilemma or with the process.  The fact that the DME that sold me the Philips machine was sold this last spring didn't help either.

At any rate, I am now using the new machine and I consider myself blessed considering the circumstances.  If you are a user of a recalled machine, I suggest that you move as quickly as possible to get an order for a new machine into the queue.

[WakeUpTime]

'There's a risk on both sides:' Philips CPAP recall impacts Mainers with sleep apnea
CBS News ME - August 5, 2021

"We could potentially be breathing in cancer-causing foam, and that’s kind of scary," Bath resident Chris Vance said.  Philips recommends consumers ask their doctor whether to keep using the device, and instructs them to register the product online to formally start the repair or replacement process.  "All we ever get from them is, ‘We’re taking this very seriously and we’ll update everyone soon,'" Vance said. "But it’s been well over a month."

The CBS13 I-Team reached out to Philips asking when a fix will be available.  A (Philips) spokesperson said in part:

We are working to address this issue as expeditiously as possible. However, given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we are not able to provide an immediate solution at this time. The company is also in consultation with regulatory authorities worldwide regarding the correction program.

ResMed pegs Philips recall to add up to $350M in sales as it struggles to meet surging demand
MedTechDive - August 6, 2021

"ResMed will not be able to fill the entire supply gap that has been created by this situation. It's supply chain constrained, not demand constrained. We expect to be in a somewhat supply chain constrained environment throughout fiscal year 2022," Farrell said. Supply is predicted to be more constrained in the first half of ResMed's fiscal 2022, which began last month, than the second half.

Analysts at Jefferies see upside to the $350 million target, which they estimate represents half of the devices recalled by Philips, if the supply situation improves. ResMed is competing with consumer technology companies, automobile manufacturers and every other business that uses semiconductors for the components.

Philips is likely in a similar situation, with Farrell noting that "there is demand from our competitor out there trying to cover their recall amount as well as catch up with the patients that need urgent replacements." Farrell said there is some overlap between the supply chains but ResMed is mainly fighting for components with companies in other industries.


Delaware Insurance Commissioner Issues Alert About Recalled Respiratory Machines
Insurance Journal - August 6, 2021

The Delaware Department of Insurance issued a notice after the company’s recall notification and (Philips') lack of communication to consumers and facilities has caused concern, particularly due to the necessity of devices in the treatment of both chronic conditions as well as facility-based usage, the department said in the notice. Recalled devices include those listed as providing respiratory treatment or support for COVID-19 patients.

While the recall notice urges immediate discontinuation of device use if possible, some individuals require the use of CPAP, BiPAP and ventilator devices and may face serious medical issues, including the possibility of death, if they do not have access to a machine. Residents using these medically necessary devices should contact their physician to discuss the best path forward for their individual needs and register in the Philips recall system online to begin a claim for replacement or financial restitution.

At this time, the company has not provided a replacement or repair timeline after issuing notice in June that the sound abatement foam in these devices may degrade, be ingested and create additional respiratory problems and could be releasing carcinogenic or otherwise hazardous chemicals into the air pathway.

[cathyf]

Something to point out is that you are constantly breathing the earth's atmosphere, and there's definitely stuff floating around in it, from dust, smoke particles, pollen, etc, etc, etc. Our bodies evolved with this constant payload of random crud constantly moving in and out of our lungs. The things that cause problems each have some particular pathology going on. With asbestos, the fibers are tiny and pointed and lodge in your lungs. With pollen, it's about individuals who are allergic, and the rest of us can breathe that stuff in all day and it's no big deal. Smoke is about the chemicals causing cellular changes and cancer. With big particles, they are an irritant, but you cough them back up pretty easily and with no permanent damage. Usually anything big enough that you can see it is OK, but the problems are the tiny things. (I live in the corn belt, and between the dust kicked up by planting, the pollen pouring out of the plants when they mature, and the dust kicked up by harvest, yeah, there's lots of stuff I'm inhaling at all times.)

So the question will come down to whether this particular particle is dangerous when inhaled, and it might turn out that it's dangerous for some and not others. We are pretty clearly at the "we don't know that it's OK so we must act under the assumption that it's not" stage of this process. It could certainly go either way.

But no matter what way it goes, stop using the #$%@^ ozone cleaners!

[DaveCar]

Hi all (newbie)
I've gone with a bacterial filter, and Im going to save the used ones in a "just in case" line of thinking.
I found that a week on a filter is pretty good.  When trying to push 2 weeks, there starts to be a smell of some kind. I assume this is just my room air "bits" making their way thru the intake filter and getting trapped in this new outlet bacterial filter.

Any idea whats going to happen to outlet bacteria filters when the water tank is in use ?
 
I tried looking around the web for a more affordable supply of these, and Im seeing a lot of "Out Of Stock" messages.
Are we going to have to deal with cheap knock-offs that will appear to fill the demand ??

[Gideon]

An AB filter is a very fine filter. As any fabric gets wet it slows the passage of air. How many of you sailors out there remember in boot camp in the pool that they had you remove your dungarees knot the bottom of your pant legs then catch air in the legs and use them as a life preserver? They held the air in them really well. Same thing happens if the filter picks up too much humidity. It is often recommended not to use humidifier with these filters. Because they add resistance down stream of the pressure sensors you may need to adjust your settings when using one.

Availability, I'm not surprised to see the supply dwindling with arguably half the machines in use being recalled and a slow, not yet started repair replacement scheduled to take a year to complete.