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Field safety notice - Philips Bi-Level PAP, CPAP, and mechanical ventilator devices

Information sign

We have been made aware of an issue with some Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. 

Philips Respironics UK has issued a Field Safety Notice. This notice says that under certain conditions the foam part of the machine can be damaged. This notice has been issued globally, so it is not specific to the UK.

These conditions, all of which are rare in the UK, include:

  • Using these devices in very high temperatures
  • Using these devices with high humidity levels
  • Using a non-approved cleaning solution on these devices

The NHS has been working closely with Philips and the Medicines & Healthcare products Regulatory Agency (MHRA) who are responsible for patient safety. There have been no known safety issues related to these products reported in the UK. No adverse events in the UK in relation to these devices have been reported to the MHRA.

For most patients the risk of not 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.

Some patients with certain very rare forms of occupational asthma related to isocyanates will need to be moved onto an alternative device. If this applies to you, please notify us at the earliest opportunity via the command centre number below.

Philips Respironics UK will be gradually replacing the filters. The notice that Philips Respironics UK have issued asks patients to register their devices. However, the NHS will do this on behalf of patients, during routine clinic appointments. Please contact us on the Hywel Dda command centre number : 0300 303 8322 (9-5pm Monday to Friday) for further information. Please select the appropriate option on the line.