Safety notice for specific breathing devices
September 22nd, 2021
We wish to let you know that Philips has issued a Field Safety Notice for specific breathing devices.
The Field Safety Notice informs customers and users of the devices of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Additionally, the notification provides details of Philips’s repair and replacement programme to correct this issue as efficiently and thoroughly as possible.
Philips has outlined the immediate actions to be taken by users of the devices:
For patients on affected BiLevel PAP and CPAP devices:
- Please contact your physician or care provider before making any changes to your prescribed therapy.
- While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment.
- Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
For patients on affected ventilator devices:
- For patients on affected life-sustaining mechanical ventilator devices, do not discontinue or alter prescribed therapy without consulting with physicians, as well as instructions for modified continued use.
You can find out further information, including the list of devices affected, on this link https://www.philips.ie/healthcare/e/sleep/communications/src-update#section_2.
Please contact your MDI Family Support Worker if you’d like to talk to them about it.