Philips CPAP Field Safety Notice - Told to stop using machine - right to refund?

alcoholfree

Hi all,

I use a Philips Dreamstation CPAP machine. They announced a safety issue back in April, although I wasn't informed of it until last week by the company I bought my CPAP machine from in the UK.

I can't post links because I've "not been around long enough" but the information is online from Philips themselves.

The key points are there are two issues - one, the foam is degrading and some people are breathing in small particles of foam, and two, the machines are giving of VOCs (Volatile organic compounds) that are known cancer causing chemicals. This is being breathed in all night, every night.

Philips have recommended immediate discontinuation of the machine.

They are "fixing the machines" but admitted it will likely take a year as there are several million of them, and they have to get regulatory approval first.

So now I'm faced with either not treating my apnea (a life threatening condition) or poisoning myself... (or buying a new machine out of pocket but - obviously - prices of other machines have gone through the roof and they are already expensive enough).

My view is this machine is clearly not fit for purpose, nor of satisfactory quality as described by the Consumer Rights Act 2015 and the retailer should issue a full refund. 

Would anyone agree or disagree? I've written to them but so far I've not heard back (it was only on Fridayt but it's Tuesday afternoon now).

Two other problems. Although I bought it from a company in the UK, I had it shipped to Spain. Back then (Dec 2018) the UK was still in the EU. But of course now it isn't. I don't know if that will affect it, although the EU has similar laws to the UK on this issue. I am a Spanish resident and a UK citizen.

The other issue is I don't want to return the machine as I may need it for legal action in the future. Hopefully not, but since using the machine (2.5 years ago), I've suffered "bronchitis" twice, both times very serious and almost resulted in hospitalisation. The first time when I was on the last-chance antibiotic before being admitted, I was told to stop using my CPAP machine too. It then cleared up... 

But it came back again, and I had the same issue. I've also had a bad chest again in recent months. I've seen a pulmonologists, had a chest x-ray, was given some medication, and a prescription to get a CT scan. When I went back for a check up, I hadn't had the scan as she told me to wait until it cleared up a bit first, and as my breathing had improved (again, she told me to stop using the CPAP machine for a while...) she said to hold off for now but to keep the prescription (this is private btw), and use it if I felt I needed it. Glad I had it. After finding out about this last week, I booked a scan and had it yesterday. I'll get the results next week and have an appointment with the pulmonologists at the start of August.

Hopefully there won't be anything wrong of course, but the fact is I've been breathing in crap and chemicals for 2.5 years.

Sorry if I've missed a discussion on this already here, I did search but can't find anything.

Thanks

unforeseen

It's a voluntary recall because there is a slim chance of it happening if the machines are cleaned with inappropriate stuff.

The safety issue has not been confirmed in the UK yet. 
Philips state that machines already in use can continue to be used. 

It is a recall notice for the US only and a safety notice for the rest of the world. 
As for not fit for purpose I disagree as it is not being recalled. 

alcoholfree

unforeseen said:

It's a voluntary recall because there is a slim chance of it happening if the machines are cleaned with inappropriate stuff.

The safety issue has not been confirmed in the UK yet. 
Philips state that machines already in use can continue to be used. 

It is a recall notice for the US only and a safety notice for the rest of the world. 
As for not fit for purpose I disagree as it is not being recalled. 

Not true I'm afraid. I wish it were so.

From the "Information for Physicians and other medical care providers​" document on the Philips uk site...

"1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life."

Note the "may be exacerbated" bit? Yes, the use of ozone based cleaning chemicals may make it worse (I've never used them btw), but they also say hot temperatures and high humidity can cause it (I'm in Spain).

From their FAQ section:

"Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature.

The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. This factor does not refer to heat and humidity generated by the device for patient use."

Note the ", and certain environmental conditions involving high humidity and temperature." Those are two separate clauses (and causes), not a combined cause.

Also the off-gassing (VOCs) is unrelated to that anyway. They are admitting it can happen from the first time you turn it on and continue to happen forever.

Philips actually advise you to ask your doctor first before stopping, but that is simply them not wanting to get sued for killing people with very severe apnea (I have "severe" by clinic definition, but some people are FAR worse).

Again, from the same document "While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment."

So Philips are recommending discontinued use (except in cases where not using a machine may result in immediate death basically and that is to save themselves from being sued even more than they are).

If a company recommends immediately stopping using a product they prouce then it's not fit for purpose. Never mind (ha), the fact it is a medical device to help improve health and it is, by their own admission, releasing VOCs into our lungs.

Now, all that said, does anyone actually have anything useful to say? Thanks.

k3lvc

alcoholfree said:

Now, all that said, does anyone actually have anything useful to say? Thanks.

With that attitude towards an established/respected member telling the truth rather than your perception it's unlikely anyone else will be along to help any time soon 

alcoholfree

k3lvc said:

alcoholfree said:

Now, all that said, does anyone actually have anything useful to say? Thanks.

With that attitude towards an established/respected member telling the truth rather than your perception it's unlikely anyone else will be along to help any time soon 

But the member isn't telling the truth I'm afraid. Read my post and you'll understand why they are wrong on a number of points but especially on the fact that they HAVE told people to stop using it (they simply tell you to speak to your doctor first so they don't get sued by the families of people who could literally die that night if they stop using them). Sorry you (and the other poster) don't understand the severity of this situation and the stress it is causing millions of people around the world. If I'm rude (I don't think I am though), it could be I haven't slept properly for 5 days. That's why I have to use a CPAP machine... 

p3ncilsharpener

Either way, you're not going to get to keep the machine and get a refund.  It's one or the other.

alcoholfree

p3ncilsharpener said:

Either way, you're not going to get to keep the machine and get a refund.  It's one or the other.

Well, some people in Australia have had refunds from retailers and not had to return the machine. Apparently they have similar consumer laws. The machine is useless, it can't be used. But it could be used to prove health damage (including cancer) in a future law case if needed, so not many people are going to want to just give them back.

Either way, Philips' reputation in CPAP is damaged for good.

born_again

Given the condition. Why buy one? When supplied via the appropriate health service? NHS supply them. So surely the Spanish version should be doing the same or your health insurance should be supplying. If the condition has been diagnosed.

Have you consulted your doctor on the matter given the "except in cases where not using a machine may result in immediate death"

What are you doing while you are after a refund? 

kayleighali

Are you based in the UK? The reason I ask is that my partner suffers and he got a CPAP machine from the NHS. Is this not available to you? I know the one my partner has (although I can't recall the model) has no foam so it should avoid this issue

alcoholfree

born_again said:

Given the condition. Why buy one? When supplied via the appropriate health service? NHS supply them. So surely the Spanish version should be doing the same or your health insurance should be supplying. If the condition has been diagnosed.

Have you consulted your doctor on the matter given the "except in cases where not using a machine may result in immediate death"

What are you doing while you are after a refund? 

Yes, diagnosed. Not in the UK, in Spain (English but resident here). Still pay tax for the NHS mind you... 

I was given one a long time again by the Spanish public health system and it was a VERY old crappy machine, so I bought my own. Then I upgraded that one (I thought...) to the Dreamstation.

I've not asked my doctor because I know full well that I am not at risk of immediate death. In the meantime I am not using a machine. It means I will sleep badly and I'll fall asleep in the day time more, as I did before I was diagnosed and treated, and I'll suffer oxygen deprivation and long-term I will suffer damage to all my internal organs including brain...

Given the pressure the health system is under because of Covid I'm not going to waste time making an appointment to ask something I know. I have an appointment at the start of August for the results of my CT scan.

alcoholfree

kayleighali said:

Are you based in the UK? The reason I ask is that my partner suffers and he got a CPAP machine from the NHS. Is this not available to you? I know the one my partner has (although I can't recall the model) has no foam so it should avoid this issue

No, based in Spain. Pay tax in the UK and have private health over here. Have been treated in the public system here for apnea though but as explained in my last post, the machines they give a shocking. Thanks.