Urgent: UK Safety Notice for Philips CPAP

[Reno]

The MHRA (UK regulatory body) have published a Field Safety Notice For Philips Respironics machines. You can find the notice here.

This includes Dreamstation, Dreamstaion Go, and REMStar SE Auto of all serial numbers manufactured before 26/04/2021. Please click the above notice for the full list.

Philips UK have released a statement.

Immediate Action to be taken by CPAP users of affected devices:

• Please contact your Sleep clinic/Doctor before making any changes to your therapy
• While Philips recommends discontinuing use, it is very important your consult your clinic so the best course is taken for you.
• Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
• For patients on affected life-sustaining mechanical ventilator devices, it is critical you take no action without your physician.

The failure rate is extremely low (something like 0.03%) so don’t panic into action. Please talk to your physician first.

- Reno

Update: Patients, Users, or Caregivers in the USA, Canada, U.K., and European Union can ring 0800 249 4578 to check the serial number of their machine.
Update 2: You can check the serial number of your machine here to see if your machine is affected.

Update 3: IMPORTANT! The Philips registration page has incorrectly identified serial numbers of some machines as unaffected. All serial numbers of the following machines manufactured before 26 April 2021 ARE AFFECTED!

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Also:

• A-Series BiPAP A30
• A-Series BiPAP V30 Auto
• A-Series BiPAP A40
• A-Series BiPAP A30

[Reno]

More UK Specific Info

An NHS staff member has told me

For most patients the risk of stopping using these devices is far greater than the risk from the issue that Philips has reported. The MHRA has advised that patients should continue to use these devices.

Also the National Patient Safety Alert states:

Do not advise patients to stop using the devices unless a risk assessment has concluded that the risks outweigh the benefits.

Risks involved in stopping treatment

Stopping treatment suddenly could have an immediate and detrimental effect on patient health. BiPAP devices are primarily used by patients with established type II respiratory failure. Withholding treatment may worsen the respiratory failure, resulting in the underlying condition getting worse and possible hospitalisation.

CPAP devices are primarily used by patients with Obstructive Sleep Apnoea (OSA), enabling them to carry out activities of normal daily living e.g. driving a vehicle, that they would be unable to do if they were to stop treatment. Withholding treatment could increase their risk of stroke, heart disease and high blood pressure. This could require hospital admission and a more invasive method of treatment and have long-term health consequences.

[Reno]

Full list
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