Announcement

**Kelly @ Intus** · 4 May 2021, 15:28

Good Afternoon,

We have spoken to Philips UK about this and they have advised the following:

Philips has determined from user reports and testing that sound abatement foam used in a number of Philips sleep and respiratory care devices may degrade under certain circumstances. This occurrence may be influenced by factors including use of unapproved cleaning methods such as ozone, environmental conditions involving high humidity and temperature*, and age of device.

To date, [Philips] have not received reports of serious patient harm related to this issue.

Any products already in market may continue to be used in accordance with their instructions for use.

To expand on the above, Philips have paused shipments of all DreamStation devices to UK customers and distributors while they investigate it further, but told us that all devices currently in use by patients can continue to be used as normal as long as it is used and maintained as instructed in the user manual. Distributors are allowed to sell their existing stock and there is no recall required. They stressed they are exercising extreme caution in taking these steps and hope to be able to resume supplying them in the coming weeks.

Kelly

**Reno** · 4 May 2021, 15:39

Any products already in market may continue to be used in accordance with their instructions for use.

That’s been my understanding too. The problem is only when/if the foam degrades.

I personally would only be concerned if your machine starts to sounds different or you start to find debris in your humidifier or tube. In which case, with or without the safety announcement, I’d contact the manufacturer.

*We were verbally told this is seemingly only a factor in Asian and South American territories currently.

Yea, that would makes sense as I can only find Philips US and Philips AU talking about it. Like I said, “unconfirmed for uk market.” I guess their assurance decreases the likelihood for the UK, but I’m sure they intend to double-check everything.

**Kelly @ Intus** · 4 May 2021, 15:43

Hi Reno,

Thank you for your reply.

We don't have access to the data that Philips have, but from our own customer data we've not had any reports of this issue and we've provided thousands of DreamStation machines over the years. So hopefully people in the UK don't see this news and panic as it seems to be - from what we can tell at least - a very small number of devices affected. The main issue also seems to be an increase in noise as the foam loses performance rather than it disintegrating. As we said above, Philips have advised that as long as they're being used and maintained as per the manual there shouldn't be any cause for concern, but we will update with more information from them when we get it.

As soon as we have any updates from Philips UK, then we will let you know.

Kelly

**Reno** · 14 June 2021, 13:04

So Philips has announced a recall, but this time the announcement is coming from their HQ in Netherlands. The recall itself so far only applies to US market, more details here.

The NL announcement says in the footnote:

* This is a recall notification for the US only, and a field safety notice for the rest of the world

So still nothing confirmed regarding Philips UK CPAP/Bi-PAP market, but a field safety notice is a type of communications sent out by medical device manufacturers in relation to actions that they may be taking in relation to their product that is on the market. So it’s possible something may come in the future.

Since the notice is dated today (14/06/2021) it’s too early to see if it appears on the gov.uk FSN lists. Be interesting if it will appears there next week.

**davederrick** · 2 July 2021, 09:37

It is on the FSN list.
We are currently talking to Philips to see if they will pay for me to buy elsewhere, I cant go 2 weeks without it.

**Rebel Reid** · 2 July 2021, 17:18

I received multiple confusing letters from Phillips about this issue and decided I needed to stop using the machine until I got clarity from the NHS.
I should say that my GP has been investigating the cause of me feeling ill every day for the past year and could not identify the cause. After not using my machine for one day, I felt fine for the first time in ages (aside from tiredness from the apnoea). I'm not saying this is proof of a link, but it is one powerful coincidence at the very least.
When I finally got through to my sleep apnoea specialist I was initially told to continue using the machine. When I conveyed my circumstances, I was told not to use it, then it was my decision to make. The good news is that my local NHS trust is in the midst of sourcing replacement machines, so I hope I don't have to wait too long as the tiredness is horrendous.

**davederrick** · 2 July 2021, 18:57

You were lucky to get a letter. I've had nothing, only found out via Facebook. Neither Philips nor Intus contacted me.

**Reno** · 3 July 2021, 19:59

It is on the FSN list.

Yes, I know. I tried to change the title but couldn’t. I decided to start new post here with the FSN. rather than continue this one.

decided I needed to stop using the machine until I got clarity from the NHS.

I can’t speak to your specific circumstances, but you should think carefully before stopping therapy. The link to the PSA DaveDerrick posted explains why most people should continue to use their devices.

If you prefer a different format, I did a video highlighting the risks on using an affected device vs stopping therapy. There are links in the description of the video for the documents. You can look at them yourself or just print them off to discuss with you Doctor.

**Kelly @ Intus** · 7 July 2021, 07:59

Good Morning davederrick,

Just to let you know Intus have/are emailing all of our customers this week, so if you have not received an email, then you will do in the next few days.

We were delayed in sending anything out as we have to wait for Philips to approved the content of our email.

Kelly

**davederrick** · 8 July 2021, 12:04

Thanks Kelly, I got it yesterday.
I've heard rumours that Philips knew about this for a while. The details on their website mentions 2020 in the risk details. They should have told people earlier.

**Reno** · 8 July 2021, 12:33

I've heard rumours that Philips knew about this for a while.

It’s not uncommon for people to complain about CPAP products when they’re fine. Not everyone adjusts well to the therapy. It may have been shrugged off initially as most of us do with random complaints, but still recorded. When a pattern started to form, they looked into it. That’s all you can ask for.

You don’t just stop business because of a complaint. You verify it. 0.03% incident is low, and yet Philips US and Philips Aus decided it needed to become public in the interest of their customers and came out with a statement that a pattern is noticed, and that they were investigating.

Once confirmed, Philips HQ in NL stepped in and issues a worldwide FSN. Despite most countries seemingly not having the climate to cause this degredation, they decide to sort all machines worldwide.

I’m not a Philips apologist. I have a large list of complaints about how this event has been handled, but knowing about it in advanced is not a valid complaint, in my opinion.

They may have known about these complaints for a while, but no evidence suggests they had confirmed it, but buried it. At least not yet, who knows what will be uncovered in the future.

We were delayed in sending anything out as we have to wait for Philips to approved the content of our email.

This does wind me up. Why should Philip get approval? Just send the customers the MHRA statement.

**Kelly @ Intus** · 8 July 2021, 13:21

Good Afternoon,

Thank you for your post.

I completely understand your frustration with the situation. Our hands were tied as we were waiting for confirmation Philips, and then we had to get approval from Philips as to the communication we were sending out, hence the delay. I can only apologise for this, and assure you we are trying to help our customers register their devices with Philips and help as and when we can.

Kelly

**Reno** · 8 July 2021, 13:46

I have no complaints with Intus, at this time. Especially since you engaged publicly on this forum about this issue ever since Philips US announced their concerns, as the dates on this thread show.

**Kelly @ Intus** · 8 July 2021, 14:08

Hi Reno.

Thank you. I do appreciate that. We are trying to help our customers as much as we can in the circumstances.

Kelly

Announcement

Dreamstation Safety Issue (Unconfirmed for UK market)

Dreamstation Safety Issue (Unconfirmed for UK market)

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