Medical Device Alert: Welch Allyn AED 10 (previously branded as MRL JumpStart). Manufactured by Welch Allyn Ltd. (MDA/2009/029)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/029 or 2009/003/019/061/009

Technical aspects
Ms Enitan Taiwo or Dr Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3122 / 3219
Fax: 020 7084 3209

E-mail: enitan.taiwo@mhra.gsi.gov.uk or  catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mr Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111
E-mail: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk 

Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx 

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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900
E-mail: 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 our website http://www.dhsspsni.gov.uk/niaic

Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

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
E-mail: iric@shs.csa.scot.nhs.uk
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922
E-mail: Haz-Aic@wales.gsi.gov.uk

Device recall due to quality and performance problems. Devices can fail suddenly and prevent defibrillation of a patient.

Welch Allyn has issued an urgent Field Safety Notice to its UK distributors.

Depending upon the date of manufacture, units may have one or more of the following problems as described briefly below and in detail in the manufacturer’s Field Safety Notice.

• Low energy shock
• Electromagnetic noise interference
• Unexpected shutdown during use
• Blown fuse resulting in device failure
• Loss of voice prompts
• Shut down in cold temperatures

The MHRA is supporting Welch Allyn’s actions to ensure that this Field Safety Notice reaches users of the device.

Locate and check for affected devices against the list of serial numbers.

Contact Welch Allyn for a replacement device.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• A&E departments
• All wards
• Ambulance services directors
• Ambulance staff
• Clinical governance leads
• Community defibrillation officers
• Coronary care departments
• EBME departments
• First responder officers
• Health and safety managers
• Intensive care units (adult, paediatric)
• Nursing executive directors
• Outpatient clinics
• Paramedics 
• Rapid responders
• Resuscitation officers and trainers
• Risk managers

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Care homes providing nursing care (adults)
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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

• Community defibrillation officers
• Community dental practices
• Community hospitals
• Equipment libraries and stores
• General dental practitioners
• Maintenance staff
• Minor injury units
• NHS walk-in centres
• Practice managers

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)

Change of address or removal from address list for Care Quality Commission:

National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Chris Grant
European Regulatory Manager
Welch Allyn Ltd
Navan Business Park
Navan, Co. Meath
Ireland

Tel: 020 7365 6780
Fax: +35 346 906 7755
E-mail: GrantC@welchallyn.com

The appendix to this Medical Device Alert is available in the PDF version only (364Kb).