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Medical Device Alert: Samaritan® public access defibrillator manufactured by HeartSine Technologies (MDA/2014/014)

Document details:

Type: Medical Device Alert
Series No: MDA/2014/014
Audience: Healthcare professionals
Published: 29 April 2014 at 15:00
Format: Electronic
Size: A4
Pages: 4
Price: Free
ISBN/ISSN: None
Author:
Copyright: Crown
   

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CAS deadlines
Action underway: 13 May 2014, action complete: 28 May 2014

Ref: MDA/2014/014 | Issued: 29 April 2014 at 15:00

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contact
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/014 or 2014/001/027/081/044

Technical aspects
Enitan Taiwo or Paul Sandhu
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road, London SW1W 9SZ
Tel: 020 3080 7122 / 7266 
Fax: 020 8754 3965
Email: paul.sandhu@mhra.gsi.gov.uk or enitan.taiwo@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)

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
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

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)

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
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
Incident Reporting and Investigation Centre (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 5801        
Email:  Haz-Aic@wales.gsi.gov.uk

Samaritan® public access defibrillatorSamaritan® public access defibrillator

Model: PAD 500P

Manufactured by HeartSine Technologies

Specific serial numbers affected

The affected devices were manufactured between February 2010 and January 2014 and have a serial number in the range 10B0010001 to 14B00461703 inclusive.

Risk of failure to deliver therapy.

The software in the samaritan® PAD 500P may miscalculate the cardiopulmonary resuscitation (CPR) rate of compression per minute being administered to the patient.

The rescuer may, therefore, be incorrectly advised by the device to ‘Push Slower’ when the CPR rate is actually at an acceptable level.

The manufacturer issued a Field Safety Notice in February 2014PDF file (opens in new window) (192Kb) providing advice on this problem.

  • Identify any affected devices.
  • Follow the manufacturer’s instructions in the Field Safety NoticePDF file (opens in new window) (192Kb) to update to software version 3.4.0.
  • Return the confirmation request to the manufacturer when the software has been updated.

Action by:

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

This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS trusts in England (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.  

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Ambulance services directors
  • Ambulance staff

Primary care trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

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

Independent distribution

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

  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • 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.

Mr James McGuinness
Heartsine Technologies Ltd
203 Airport Road West
Belfast
Antrim
BT3 9ED
Northern Ireland
Tel: 028 9093 9400
Fax: 028 9093 9401
Email: james.mcguinness@heartsine.com

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

Page last modified: 28 April 2014