Medical Device Alert: LIFEPAK 20/20e defibrillator/monitor, manufactured by Medtronic/Physio-Control (MDA/2010/070)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/070 or 2010/006/003/081/021

Technical aspects
Enitan Taiwo or Nicole Small
Medicines & Healthcare products Regulatory Agency
Market Towers 1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3122 / 3310
Fax: 020 7084 3209

Email: enitan.taiwo@mhra.gsi.gov.uk or nicole.small@mhra.gsi.gov.uk

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

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 Central Alerting System website (external link).

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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

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 (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Due to component failures, which affect AC (mains) and/or DC (battery) operating power, there is a risk that the defibrillator will not deliver therapy.

The corrective action programme initiated by the manufacturer will take approximately two years to complete.

Problem 1: No DC (battery) operating power
Current leakage can prevent operation when using DC battery power.  Failure of DC power can result in an inability to deliver defibrillation therapy, if no AC power is available. The global failure rate is 0.9% to date.

Problem 2: No AC (mains) operating power
A component failure prevents AC power operation and prevents battery charging capability. Failure of AC power can result in an inability to deliver defibrillation therapy if DC power is depleted.

The global failure rate is 0.7% to date.

Solution
Affected devices may have problem 1, or problem 2, or both problems. The following phased corrective actions to replace the power supply board have been initiated:

• Phase 1 DC power – identifies devices at a higher risk that accounts for 92% of all DC power failures. The manufacturer expects to complete this phase in 9 to 12 months.
• Phase 2 AC power – identifies the remaining lower risk devices that will be updated upon completion of phase 1. The manufacturer expects phase 2 to take an additional 9-12 months to complete.

1. Assess the need for a back-up or alternative device whilst awaiting corrective action.

2. All users should ensure that:

• they are aware of manufacturer’s Field Safety Notice.
• the manufacturer’s recommended daily inspection and testing as per the operator’s checklist are performed.
• where possible, devices are connected to AC mains power and the DC battery kept continuously on charge. 

3. The manufacturer has contacted all affected customers. However, if you wish to check if your device is affected, refer to the Field Safety Notice.

• Be aware of the two year timeline for completion of the corrective action. Assess the need for a back-up or alternative device during this period.
• If your device exhibits either or both problems, report the failure of the device to the manufacturer and to the MHRA. Arrange for repair of the device with the manufacturer.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• 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 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 consultants
• A&E departments
• A&E directors
• A&E nurses
• Adult intensive care units
• All clinical departments
• All staff
• All wards
• Anaesthesia, directors of
• Anaesthetic medical staff
• Anaesthetic nursing staff
• Anaesthetists
• Biomedical engineering staff
• Cardiac laboratory technicians
• Cardiac pacing technicians
• Cardiologists
• Cardiology departments
• Cardiology nurses
• Cardiology, directors of
• Cardiothoracic departments
• Cardiothoracic surgeons
• Cardiothoracic surgery directors
• Clinical governance leads
• Coronary care departments
• Coronary care nurses
• EBME departments
• Equipment stores
• Health and safety managers
• Intensive care units
• Intensive care, directors of
• Medical directors
• Medical libraries
• Midwifery staff
• MRI units, directors of
• Neonatal nurse specialists
• Neonatology departments
• Neonatology directors
• Outpatient theatre managers
• Paediatric intensive care units
• Patient transport managers
• Resuscitation officers and trainers
• Risk managers
• Theatre managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

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

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

• Community defibrillation officers
• Community hospitals
• Community nurses
• Equipment libraries and stores
• General practitioners
• Minor injury units
• NHS walk-in centres

Lezlie Bridge
Senior Regulatory Affairs Specialist - UK & Ireland
Medtronic Ltd
Building 9, Croxley Green Business Park
Watford
WD18 8WW

Tel: 01923 212 213
Fax: 01923 202 550

Email: lezlie.j.bridge@medtronic.com

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