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Originator: MHRA Medical Device Alerts

Issue date: 02-May-2018 15:04:17

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: Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated

Broadcast content: Manufactured by Draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment

Additional information: Do not cascade to Primary Care

Alert reference: MDA/2018/014

Action underway deadline: 18-May-2018

Action complete deadline: 05-Jun-2018


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency