MHRA Medical Device Safety Information – MDSI2406U
Published on 18 October 2024
From: NHSScotland Assure
Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support
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The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the webpage on which MDSI2406 was based on 02 October 2024.
The MHRA has issued the following update: Philips Respironics have now published a further Field Safety Notice (FSN) on actions they will be taking to address this issue. This includes updates to the instructions for use (IFU) for the BiPAP A40 and A40 Pro devices, and financial/replacement options for affected users. Please see the FSN for further information. Patients should continue to follow the advice of their healthcare professional. The advice within this DSI remains unchanged.