We have been made aware of a potential issue with Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
Philips 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- very high temperatures, high humidity, and the use of a non-approved cleaning solution- are rare in the UK.
The NHS has been working closely with Philips and the Medicines & Healthcare products Regulatory Agency (MHRA) who are responsible for patient safety. Reports of incidents related to this issue are rare, and no incidents of harm have been reported in the UK.
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.
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. If you are not contacted by your clinician, you do not need to change devices and you can continue to use your device as normal.
Philips will replace the current sound abatement foam with new material as quickly as possible. The notice that they have issued asks patients to register their devices. Please note that we will do this on your behalf so there is no need for you to register your device directly with Philips individually.
If you would like to discuss further, please telephone: 01633 238832 or 01873 733259