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Originator: MHRA Medical Device Alerts

 
Issue date: 23-Jul-2020 13:01:17

Action by recipients:
  • MDA/2020/022-Pilot-a

Action category: Action

Title: Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed

Broadcast content: Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.  

Note: as part of an ongoing pilot this alert is being sent only to Trusts and other organisations in England which:
  • the manufacturer has confirmed were supplied with the device;
  • have not responded to the Field Safety Notice. 
This pilot will allow us to assess the effectiveness of sending more targeted alerts, where we have sufficient information to enable us to do so. This aims to reduce the burden on those organisations that we know are not affected. Different distribution arrangements may apply within the Devolved Administrations.  

CAS Liaison Officers:
  • If you receive this alert via email and it appears in 'View my alerts' then please action in the same way you would for any other MDA.
  • If you do not receive this alert via email and it does not appear in 'View my alerts' then it has not been identified as relevant to your Trust.


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

Alert reference: MDA/2020/022

Action underway deadline: 06-Aug-2020

Action complete deadline: 20-Aug-2020

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency