25 June 2021

Page last updated on Friday 6 May 2022. 

In June 2021, a National Patient Safety Alert was issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for some Philips CPAP and CPAP-like devices. 

Philips also issued a Field Safety Notice. This notice says that under certain conditions the foam part of the machines can be damaged. This notice was issued globally, so it is not specific to the UK. These conditions are: very high temperatures; high humidity; and the use of a non-approved cleaning method (the advice from our CPAP team has always been to unplug your device from the mains and simply use a damp cloth for cleaning).

The MHRA advised that reports of incidents related to this issue are rare and no incidents of harm have been reported in the UK.

The available evidence suggests that the health risk to patients of stopping using their devices significantly outweighs the safety risks of using the devices if patients do not have ready access to an alternative. The MHRA is therefore advising that patients should continue to use these devices, while Philips enact a repair and replace programme.

More information is available on the MHRA website (download the pdf at the bottom of the MHRA page for full notice). 

What do I need to do? 

You should not need to do anything.

We have identified all of our patients affected by this recall and will have sent you a letter, text message or both. This text will have come from mobile number 07860 039092. Please do respond to texts from this number as it will help inform our response to this situation.

If you have not heard from us and think you should have done, then please get in touch with our CPAP team on 01223 638010 between 09:00-17:00 Monday to Friday. 

You can also register your device on the Philips website, though our team should have already done this for you.

Repairing and replacing devices

Philips are now beginning to replace devices, but their repair programme is not yet live. 

We are regularly receiving brand-new devices from Philips. As this equipment makes it way through to us, we will contact patients and invite them into our hospital to have their device replaced. This is being done in order of clinical priority, as judged by our CPAP consultants and nurses, drawing upon clinical data. 

In the meantime, please continue to use your current device. 


Frequently Asked Questions (FAQs)

Is my device affected by this issue?

If your device is not a Philips device, it will not be affected by this issue.

If you have a Philips device, please check the list of devices affected by the field safety notice on the Philips website. 

How long will it take for my device to be replaced?

Philips is currently setting up a process for replacing affected devices and we are awaiting further information from them.

Please be aware that this likely to take several months and possibly up to one year.

I have a Philips device. Should I stop using it?

The MHRA has advised that patients should continue to use these devices.  

The advice from our consultants is that if you have an older machine that is working and you are happy to move back onto it, then that is what you should do. However, if you don’t have an older machine then the advice is to continue using your Dreamstation as normal.

If you prefer the Dreamstation it is also fine for you to continue using it.

If you do experience anything out of the ordinary with your machine please contact us on 01223 638010 and we can book you in to speak with a clinician.

 

 

I have two machines. Can I return one to you?

We have recently teamed up with a courier service to collect second machines, so that we have sufficient stock to allocate to all our patients.

Please contact us on 01223 638010 and we can arrange a collection.

I received a letter from you asking to call if I haven't responded to text messages.

The texts were sent out as a part of a fact finding exercise to see how many hours on average our patients use their machines every night. 

You can find out how to obtain that information in the video above. Please then reply to the text with the numbers. 

Can I arrange an appointment with my doctor to discuss this issue?

Yes. Our CPAP team are keen to see you so that we can discuss each case individually and give you advice relevant to your situation. To do this, we need to gather more information, so please bear with us while we undertake this work. Once we are able to arrange appointments we will be in touch.

When will I next be seen by the team?

Our clinicians and practitioners are currently working through the backlog of patients that was created due to COVID-19. You will receive a telephone or in-person consultation depending on what the team think is best. 

Please wait to be contacted by us to be given an appointment. 

My machine has not been serviced in a while. When can that be done?

Annual servicing is not essential for the perfect functioning of the machine, so there is nothing to be worried about if it has been more than a year since your last one. As long as everything is working normally then it should be fine.

Our practitioners are working to contact patients and check everything is ok, but if your machine is now working as you'd expect then please call our practitioners on 01223 638526.

I am due to start CPAP treatment. Will this be impacted?

No. 

If you are a new starter or due to start CPAP treatment soon, there will be no delay to you starting treatment.

We are ensuring new starters still have access to devices. 

I need a new mask / hose / filter please.

Please call our mask replacement team on 01223 638890.

I can buy a CPAP machine privately online. Why can't Royal Papworth buy these devices?

For patient safety, it is critical that we only buy our CPAP machines from approved NHS suppliers. 

I have seen that Philips have also recalled certain V60 and V60 Plus ventilators. Does that impact you?

There is no need to worry about this if you are a patient of Royal Papworth Hospital. This does not affect our patients or our services.


Contacting us

Please see our frequently asked questions above in the first instance to answer any queries you might have.

If you still have a query and need to contact us, please call us on 01223 638010 between 09:00-17:00 Monday to Friday. You may be asked to leave a voicemail message. We will get back to you as soon as we can. 

CPAP: Hours of use

As part of our investigations and to be able to give you the best advice relevant to your situation, we may ask you for the 'hours of use' from your CPAP device. The below tutorial talks you through how to find this information. 

 

Message from Dr Ian Smith, Deputy Medical Director

Our Deputy Medical Director and sleep consultant, Dr Ian Smith, provides an update on the CPAP National Patient Safety Alert (25 June 2021).