Central Alerting System
View Alert


Originator: MHRA Medical Device Alerts

Issue date: 21-Dec-2018 14:00:02

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: Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation.

Broadcast content: Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.

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

Alert reference: MDA/2018/037

Action underway deadline: 04-Jan-2019

Action complete deadline: 15-Feb-2019

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency