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

[WakeUpTime]

"Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use"
...
"The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.
...
"Upon discovery and further analysis of this issue, we proactively took corrective action. We placed shipment holds on all affected products (???) on orders from our healthcare provider customers. We continued our rigorous testing and analysis to further understand the reports, and we began engaging regulatory agencies."

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

Philips is recalling some machines that have been used significantly longer than 5 years.  It'll be interesting how they recall those devices.

I find Philips' use of the phrase "already begun the process" misleading and insulting to end-users, since they're again focused purely on their "real" customers - the DME distributors who have/had a current inventory supply of NEW Philips machines on the recall list (likely DreamStation 1 units).  They haven't yet "begun the process" with end-user; they've only begun to setup the logistics of the future returns.  They've got a long way to go.

Perhaps Philips will use this initial batch of new product DME inventory returns of DreamStation 1 models to initially modify and utilize as their "float" for future replacements.

[racprops]

"In an earlier post (I can't remember where I saw it) someone mentioned that they noticed a different level of airflow AFTER they removed the phone in their machine, so they adjusted their settings accordingly.  Did you find that?  If that's true, there are several implications:"

That may as well been I, I did note a in-cress in air flow with the foam removed.

Specially when I first started it up. I believe the system was able to adjust its self to near what would be normal within a few minutes.

It did not do what I have called a run away cycle where I have had a system incress the air flow and pressure to the point of blowing the mask off my face.

Currently it does seem to have a slightly greater air FLOW, the pressures seem correct as it reads out them correctly.

Air flow VS air pressure has long been a problem for me with Phillips ASV machines.

When I first started using the Dreamstation ASV I nearly send it back as defective as I was fighting with it doing odd things with air volume, I learned that the setting of Mask TYPE is very important, the machine came with this setting at ZERO 0, and because of that it would go hunting up and down with the air flow. This is NOT made clear in the instructions.

I was trying everything to control this even resetting it by pulling the plug when it did it. Nothing seemed to work until I hit on the idea of changing that setting...AND THAT was it, I use a ResMed F20 mask so I could not find a setting for it so I tried X1..bingo stable air flow/volume. In fact testing higher setting product MORE air flow but I found them to be too much so I use X1.

In fact you can read this volume on one of the tech screens during operation:


This is a special screen in the ASV machine called Monitor Parameters (I took a photo of this screen), you reach it by holding down the ramp and pushing in and holding the main control knob until it appears.  The same way you reach the adjustment windows with the system not running.

It show 6 parameters but I do not have a O2 reader so that SpO2 reading is blank.

The cmH2O is my exhale pressure and the Vte is its air flow volume, these number will change to my inhail pressure of 18 CMH2O and a reading around 600 something or higher, it changes as to how strongly or deeply or hard I breath.

I find around 500 to 900 most enjoyable.

I do not like this flow or volume below 400 or above 1000.

These readings seem normal as they are within my normal range, just favoring slightly higher volume than before which I LIKE, and my body seems to also like.

Much over 1000 inhaling will often cause mask farts.

Rich

[attachment=33016]

[btreger]

Fact Check Time:

Over the past several days I have read several posts that I think deserve more provable data to back up the claims. I think this is too important of a problem, your health, and is not a question of which option is better than that one.

One post stated that users have been complaining for years of the medical side effects of using their Philips CPAP equipment, but have never received any responses about their complaints.

Another post stated that the ResMed products have the same problems as the Philips products. They just haven't been recalled.

I hope that this is not like saying all cars have doors.

So please provide more info on these two posts.

Thanks

Burt

[racprops]

Here is what I know:

Phillips has issued a recall. These is foam in their current Dreamstations that can go bad.

The Resmed machines are not under any recall. And I was ordering one after being told they have NO FOAM in these machines.

BUT it was shown that they do, it is inside the fan housing, which is almost never opened as the replacement fans come in this housing. SO no repair service men never open them and thus never seen the foam.

Now it may very well be a different type of foam, and may very well never decompose and go bad as has Phillips' foam BUT I am not willing to spend $1300.00 on a refurbished used machine and pray it never does.

I removed the foam from my Dreamstations myself. Problem solved for any future contamination.

I found no deterioration of the foam in the two Dreamstations I did this to. I still need to be concerned over possible harmful gasses emitted by this foam before I was warned and removed it. That adds up to 4 to 5 years of 100% nightly use of 7 to 8 hours per night.

I have seen no performance problems with my Dreamststion after I removed the foam.

End of report.

Rich

[SarcasticDave94]

Bottom line is the action and direction is up to the individual. There's no wrong answer on the patient choosing to dump the Respironics and get ResMed or to rip the foam out, or whatever other something else choices there are. You the individual choose what you prefer.

[WakeUpTime]

I thought it might be interesting to "poll" PAP users' feelings on the Philips Respironics brand name as a result of the recent recall news and Philips responsive actions to date:

http://www.apneaboard.com/forums/Thread-...hases-POLL

Please consider contributing. An individual's vote preference is confidential in this poll. Only the overall results are published.

[hegel]

"I found no deterioration of the foam in the two Dreamstations I did this to. I still need to be concerned over possible harmful gasses emitted by this foam before I was warned and removed it. That adds up to 4 to 5 years of 100% nightly use of 7 to 8 hours per night."

Possible harmful gasses?

I think the headline is where you state " I find no deterioration...".

I'm still waiting for more information about the issue: how many machines/patients have been affected and how. It may be a tiny number of machines and people.

I have no possible way to know anything about possible harmful gasses.

I've used machines for about ten years with no ill effects whatsoever. When I smoked, I felt ill effects. Never with a cpap, including PR machines. I would imagine that the material they use in their foam is approved by medical agencies. It's certainly not asbestos.

My point is, we're all on sidelines speculating. Worrying about years of breathing possible harmful gasses and spreading accusations before the facts are known is not productive.

[SarcasticDave94]

Me wonders out loud

Like my years of smoking cigarette cancer sticks, do the bad effects take years to manifest? I quit smoking 27 years ago, but COPD was diagnosed 20 or so years afterwards. Scary thought there.

[racprops]

OK Here is Phillips official statement:

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?
The recall notification (U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.

Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.

In the event of exposure to degraded foam:

• The potential risks of degraded foam exposure include:
o Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.
• To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

In the event of exposure to chemical emissions:

• The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
• To date, Philips has not received reports of patient impact or serious harm as a result of this issue.

[WakeUpTime]

This is in a different category than smoking.  If I smoke, I'm going to cough.  If I unknowingly several tablespoons of Round-Up every day, over many months, I'm likely to develop problems over a year or two (or ten).  Yet there will be others who get seriously ill only after a few weeks, since they already have other underlying conditions.  Round-Up may not have killed them, but it was a significant contributing factor to their premature demise, or other life-impacting ailment.  

Philips has already admitted to several issues, including...

- the foam contains a proven cancer-causing element
- the foam does deteriorate and will enter, unimpeded, into the user's lungs
- the foam deteriorates more rapidly for those who use ozone products like SoClean
- that same foam composition has existed in many Philips systems for a very long time

Until there is more independent analysis, and involvement from other agencies, no one can say for sure what level of cancer-causing chemicals has been ingested.  However, it's absolutely known to have been occurring to some degree.

According to Philips,

"In the event of exposure to degraded foam, the potential risks of degraded foam exposures include irritation (skin, eye and respiratory tract), inflammatory response, headache, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects."