Medical Device Alert: Samaritan public access defibrillator manufactured by HeartSine (MDA/2012/079)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/079 or 2012/009/011/081/001

Technical aspects
Enitan Taiwo and Catriona Blake
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7122/7219
Fax: 020 8754 3965
Email:  enitan.taiwo@mhra.gsi.gov.uk
catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mark Grumbridge
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email:  mark.grumbridge@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Risk of failure to deliver therapy caused by two different faults:

1. Some defibrillators may repeatedly turn on and off when not in use, leading to unexpected battery depletion.
2. Defibrillators with early versions of the battery management software may switch off after delivering a single shock or give a premature low battery warning.

The manufacturer issued a Field Safety Notice (471Kb) (FSN) in September 2012, providing advice on management of the defibrillator.

• Identify affected defibrillators (see below for serial numbers).
• Increase frequency of checks to daily.
• If the LED is red or unlit, contact the manufacturer immediately for a replacement defibrillator.
• Consider relocating the device so that faults are detected promptly.
• Return the confirmation request in the manufacturer’s FSN issued September 2012 and HeartSine will send you an upgrade kit containing:

1. reserve Pad-Pak (battery) and instruction ‘hang tag’

2. the software upgrade, USB cable and installation guide.

Once the upgrade pack is received follow the instructions to ensure that:

• a reserve battery pack is available in the carry case for emergency use
• the ‘hang tag’ with instructions for reserve battery use is attached to the device
• the software is updated.

Action by

Community defibrillation officers and staff responsible for the use, maintenance and purchase of these devices.

This MDA has been sent to:  

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters) for information
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (equipment coordinators)
• Local authorities in Scotland (equipment coordinators)
• NHS boards and trusts in Wales (chief executives)
• Primary care trusts in England (chief executives)

Onward distribution

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

• Community defibrillation officers
• Community hospitals
• General practitioners
• Practice nurses
• Practice managers
• Maintenance staff
• Minor injury units
• NHS walk-in centres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Care homes
• Clinics
• Domiciliary care providers
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

HeartSine Technologies Ltd
Canberra House
203 Airport Road West
Belfast
BT3 9ED

Tel: 028 9093 9400
Fax: 028 9093 9401
Email:data@heartsine.co.uk 
Website: www.heartsine.com

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk