Medical safety alert

Samaritan public access defibrillator - risk of failure to deliver therapy

(HeartSine) may repeatedly turn on and off when not in use, switch off after delivering a single shock or give a premature low battery warning. (MDA/2012/079)

CAS deadlines

Action underway: 11 December 2012, action complete: 7  January 2013

Note: These deadlines are for defibrillators to be identified and HeartSine contacted.

Device

Samaritan public access defibrillator

Samaritan public access defibrillator.

Model: PAD 300/PAD 300P.

Manufactured by HeartSine Technologies Ltd.

Specific serial numbers are affected.

Samaritan PAD 300/300P distributed from August 2004 to December 2010 with a warranted life of up to seven years.

The following serial number ranges are affected with one or both of the identified faults.

0400000501 to 0700032917 inclusive
08A00035000 to 10A00070753 inclusive
10C00200000 to 10C00210318 inclusive

Note: this range supersedes the one in the manufacturer’s FSN.

Problem

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.

Action

  • 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.

Distribution

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

Please bring this notice to the attention of relevant employees in your establishment.  Below is a suggested list of recipients.  

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.

Manufacturer contact

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

Feedback

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

England

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

Northern Ireland

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

Further information about SABS can be found on the SABS website

Scotland

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

Wales

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

Download documents

Medical Device Alert: Samaritan public access defibrillator manufactured by HeartSine (MDA/2012/079) (51Kb)

Help us improve GOV.UK

Don't include personal or financial information, eg your National Insurance number or credit card details.