CAS-ViewAlert

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Originator:		National Patient Safety Alert - MHRA
Issue date:		18-May-2023 11:01:17
This alert has been issued to:
		Care Trusts Mental Health Trusts Specialists Trusts Learning Disabilities Trusts Mental Health & Social Care Trusts Ambulance Trusts Mental Health & Learning Disabilities Trusts Acute Trusts Community Trusts
		Other contacts Independent Healthcare Providers (registered with CAS) Clinical Commissioning Groups Special Health Authorities Territorial CMOs in Northern Ireland, Scotland & Wales
Action category:		Action
Title:		Removal of Philips Health Systems V60 and V60 Plus ventilators from service - potential unexpected shutdown leading to complete loss of ventilation
Broadcast content:		This alert concerns all Philips Respironics V60 and V60 Plus non-invasive ventilators. The MHRA is issuing updated advice that these ventilators must be permanently removed from use. This advice is issued following further in depth review of additional safety evidence and recent regulatory issues in consultation with a number of external stakeholders and the MHRA’s independent Interim Devices Working Group. It has been concluded that the benefits of these devices no longer outweigh the potential risks. The attached National Patient Safety Alert contains further information and action for providers. All providers: please note that the deadline in the attached is 30 September 2023. However for NHS Trusts that record a response via the CAS website, the completion deadline has been input as 02 October 2023 to allow for the 30 September falling on a non week-day. Please note this is a different alert to the previously issued National Patient Safety Alert of 29/03/2022.
Additional information:		This alert is not relevant to Primary Care.
Alert reference:		NatPSA/2023/005/MHRA
Action underway deadline:		22-May-2023
Action complete deadline:		02-Oct-2023
Attachments:		NatPSA_2023_005_MHRA.pdf