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Originator: MHRA Medical Device Alerts

 
Issue date: Originally issued on 30-Jun-2020 10:00:02. This version was issued on 30-Jun-2020 10:00:02

Action by recipients:
  • MDA Pilot (a)

Information to recipients:
  • MDA Pilot (b)

Action category: Action

Title: Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail

Broadcast content: Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy. 

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 receiving this alert, please action in the same way you would for any other MDA.


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

Alert reference: MDA/2020/018

Action underway deadline: 14-Jul-2020

Action complete deadline: 28-Jul-2020

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency