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Originator: MHRA Medical Device Alerts

Issue date: 17-Jun-2020 14:00:22

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

Action category: Action

Title: Philips HeartStart MRx Monitor/Defibrillators may fail to deliver therapy without alerting the user to a fault in the event of internal damage.

Broadcast content: The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

Additional information: This alert is not relevant to Primary Care.

Alert reference: MDA/2020/016

Action underway deadline: 01-Jul-2020

Action complete deadline: 15-Jul-2020


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency