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Originator: MHRA Medical Device Alerts

Issue date: 17-Jan-2019 11:00:02

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • 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

Action category: Action

Title: Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension

Broadcast content: Manufactured by GE Healthcare – Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.

Additional information: NHS England Regional offices: do not cascade to primary care.

Alert reference: MDA/2019/001

Action underway deadline: 31-Jan-2019

Action complete deadline: 14-Mar-2019

Attachments:

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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency