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

[WakeUpTime]

"It would sound like the foam is in the path of the airflow in these Respironics.

Don't accept a Respironics.

ResMed isn't identical in this foam issues and isn't affected like 

Respironics."

That's become a common summary for many.

Ozone cleaning methods, like an advanced cleaning method, does indeed significantly increase the degradation of softer materials (silicone, softer plastics, seals, rubber, etc.) - and as a result, more rapidly ages those components.  

So an additional summary may be:

Philips machines have a design flaw in how the airflow circulates around (and through) the sound-isolating foam, and in the composition of the foam itself with the use of a chemical that is known to be cancer causing, and in that foam's lack of long-term composition strength that allows it to degrade over time - accelerated by the use of advanced internal machine cleaning products such as ozone cleaners.

Indeed. I, for one, would not let the manufacturers of these ozone-generating devices off the hook in this Philips-Respironics PAP device foam outgassing recall fiasco.  I started using a new generic ozone-generating "CPAP Cleaner"  ... the mask cushion and the forehead protective piece ... turned a bright yellow color.

The discoloration may be a useful piece of evidence in some future class action, as to the effect of some ozone-generators on plastic polymers, if not on the sound insulating polymer foam in question.

[SarcasticDave94]

That would likely be a too coincidental happening for me to buy.

[btreger]

I think Dave just made one of the best comments made on this thread. We have a choice, we can go on and just rehash the same information over and over again, or we can just admit that we have screwed. And there is nothing we can do to correct what has already been done.

[glenlyon602]

I'm happy to be joining this board today!  My DreamStation went on the shelf Monday and I have now finished a second satisfactory night on a ResMed machine.  Different experience that takes some getting used to but not bad so far!

I wondered if anyone has answers to a few basic framing questions that occur to me about the Philips recall:

1. What is the USA market share in a normal year for Philips vs. its competitors?
2. What is the USA percentage of Philips machines being recalled vs. Philips machines not being recalled?
3. What is the percentage of DreamStation AutoCPAP machines made vs. other DreamStation models?


I am guessing they are all very high percentages but would appreciate any numbers or links anyone has.

[cathyf]

On another note, it could be just a coincidence, but several days after registering my mobile phone number at the Philips Recall site, I'm getting many almost daily telemarketing (phishing) calls on that number.  I've used that number for years and never had that before.  Likely just a coincidence, but I thought I'd see if it happened to any others.  No doubt those database entries will be copied repeatedly and sent to other Philips departments and perhaps even outside Philips.

Totally off topic, but how the heck did you get to mid-2021 with a mobile phone that does NOT get multiple telemarketing calls hourly?!?!?

(We got my mom a new cell phone and new number on Saturday. Took approximately two hours for the first notification that her car warranty was about to expire.)

[Glen e]

My brother and I are both on cpap machines. I’m on an airsense 10 and he’s on a DS unit. He has shelved his DS unit and since my OSA is virtually cleared up with substantial weight loss (>45 lbs), I gave him mine to use. He feels the diff is night and day, the resmed works much better for him.

so he spent 8 hours yesterday on the phone with everyone: his sleep tech, his DME, his pulmonologist and GP.

AND GOT NOWHERE….everyone referred him back to philips, which as we know now, goes nowhere.

So now he’s accepting that he will get raped on the open market for a Resmed from the online sources and will order one as soon as his pulmonologist sends over an updated Rx…..Unfortunately it has reached a point to where we need to be a little less outraged at the gouging going on , and buck up and pay the money and get back to a healthy situation. He has a heart condition that won’t wait for the state AG to correct the price gouging.

[btreger]

Philips Respironics:

1. Is a very large Multi-National Corporation
2. They manufacture and distribute a very long list of medical equipment for the Hospital, any Medical Centers around the world. They also distribute to individual Doctors and Individuals like us around the world, and a much larger list than I have access to.
3. They employ hundreds of engineers, medical scientists, supply chain managers, and lawers. Just to name a few of the thousands of employees they have. This does not include how much they outsource and to how many countries
4. The foam they used was not a mistake. They knew more about it than we will ever know. They did a very careful cost-benefit analysis, that was done from the top down, including senior management, legal, engineering, and medical scientists. Knowing the potential medical harm this foam could cause they would only use it for one product cycle, about 5 years. I guess they felt fairly confident no one using these products would show any serious side effects.
5. This was done of course to save money and make more profit.
6. You can see that their new line of products does not use the same foam.
7. This was not a change they made overnight. It takes years of engineering and testing before it gets certified to go to manufacturing.
8. Class Action Law Suits. So now we have to deal with lawyers who want to make more money off us. Lawers would like to see bodies piling up, thank God that has not happened yet. If there are any serious illnesses that come about from the use of their recalled products, hopefully, none, but it may take years to happen.

Ok: I needed to get all that off my chest. These are my words and my thoughts. I am speaking as a retired Engineering Manager. I know how large corporations work, and I know how decisions are made and how products are brought to the marketplace. This was no mistake in my opinion.

[WakeUpTime]

1. What is the USA market share in a normal year for Philips vs. its competitors?

At the end of 2019, a survey conducted by HME (Home Medical Equipment) News, found:

"According to the survey, Philips Respironics currently has 62.8% of the flow generator market. 

(ResMed is the next biggest player with a 32.2% share of the market.)"

[HME Survey, 2019 Year End]

A lot may have changed for both Philips and ResMed, from Jan 2020 until Jun 2021.  Philips sold a lot of invasive ventilators to medical departments around the world, as a result of COVID.

Also, ResMed system installations "may" be increasing significantly at this moment, since the announcement of the Philips recall.  Later in the year, once Philips replacements some units with new models (while others only get "fixes"), those new installations will add to Philips' market share - which is misleading because the Philips announcement will obsolete many recalled Philips unit serial numbers.  

So, by Philips stating after the 2021 year end that they "sold" (est.) 300,000 new PAP systems, those new DreamStation 2 sales (or modified DreamStation 1 system variations that were yet unopened by Philips or at DMEs in inventory) were NOT new additional installations that increase their market share.

[qwerty42]

I'm a chemist, and have been looking at the chemistry of the polyester-based polyurethane foam degradation process. I haven't found anything authoritative yet, but there are two degradation pathways, one by water, one by fungus, both resulting in the same degradation products. The product that is a gas would be isocyanic acid, HNCO, H-N=C=O. It is a poison, more acidic than vinegar, reacts with amino acids, so it is a danger to the lungs. It's present in smog and cigarette smoke. In dry and cool environments, in the dark, the foam is stable.

Here's the odd thing: if there is enough humidity around to cause the degradation, the isocyanic acid will remain soluble in the water. I think it's the heat part that is important, because hot water would lower the solubility of the acid and drive it back into the air. So the combination of very high humidity then a cycle of heat would be needed. I suppose that could happen if the machine is used at night in a non-air-conditioned space, then sits during the hot day.

Or give it ozone. That stuff reacts with everything. You'll recognize the smell of ozone easily; it's the smell of a kitchen motor (the kind that makes sparks in the back) or a Xerox machine.

I think there might be some small possibility that phenyl-isocyanate could be the gas, but I'd want to see some headspace analysis of the foam first.

No need to wonder. Philips' well-buried physician's info document regarding all of this is here for anyone to read: https://www.philips.com/c-dam/b2bhc/mast...viders.pdf

Pasted from that document:

"Foam Degradation Exposure

• Potential Hazard: Philips has determined from user reports and lab testing that under certain circumstances the foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user of its Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) and Mechanical Ventilator devices. The foam degradation may be exacerbated by environmental conditions of higher temperatures and humidity in certain regions. Unauthorized cleaning methods such as ozone may accelerate potential degradation.

• The absence of visible particles does not mean that foam breakdown has not already begun. Lab analysis of the degraded foam reveals the presence of potentially harmful chemicals including:
- Toluene Diamine
- Toluene Diisocyanate
- Diethylene glycol

• Potential Harm: A patient may be exposed to foam particles by inhalation or ingestion that could result in harm. There has been no patient death reported to date.

• With limited reports, the following risks are considered:
- Foam particles may cause irritation and airway inflammation, and this may be particularly
important for patients with underlying lung diseases or reduced cardiopulmonary reserve.
- The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects.
- 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.

Volatile Organic Compounds (VOCs) - e.g. Chemical Emissions from Foam

• Potential Hazard: Lab testing performed for and by Philips has also identified the presence of VOCs which may be emitted from the sound abatement foam component of affected device(s). VOCs are emitted as gases from the foam included in the CPAP, BiLevel PAP and MV devices and may have short- and long-term adverse health effects.

Standard testing identified two compounds of concern (COC) may be emitted from the foam that are outside of safety thresholds. The compounds identified are the following:
- Dimethyl Diazine
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)-

• Potential Harm: During initial or subsequent operation of the device, a patient may be exposed to VOCs. To date, Philips has received no reports of these types of safety issues alleged to be related to chemical emissions, but toxicological risk assessment indicates that VOCs levels exceed a safe exposure threshold. We have considered the following risks:
- VOCs may cause irritation and airway inflammation, and this may be particularly important for patients with underlying lung diseases or reduced cardiopulmonary reserve.
- The potential risks of chemical exposure due to off-gassing include: headache/ dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/ vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of this type of exposure."

[b.e.wilson]

I'm still using my Philips machine. What is scary to a lawyer is normal everyday risk for everyone else. Low humidity, good AC system, no hint of degradation or gasses in my 4.5-years-old machine.