Medical Device Alert: NicoletOne® System EEG recorder manufactured by CareFusion 209 Inc, formerly Viasys Healthcare Inc (MDA/2010/061)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/061 or 2010/005/010/081/027.

Technical aspects
Sharon Knight and Geoff Smith
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3202/3198
Fax: 020 7084 3209

Email: sharon.knight@mhra.gsi.gov.uk or geoff.smith@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

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

The standard NicoletOne System has a left/right (L/R) headbox configuration. However, NicoletOne Systems with software versions 5.3, 5.4, and 5.7 also have right/left (R/L) headbox configurations.

There is potential for misinterpretation of EEG results when using the R/L configurations.

CareFusion has received reports of misinterpretation of EEG results when using the right/left headbox configurations. There is potential to confuse the EEG outputs from the left and right sides of the brain.

This may result in unnecessary diagnostic tests, treatment delays and incorrect diagnosis leading to inappropriate medication or inappropriate surgery.

Follow the directions in the manufacturer’s Field Safety Notice to:

• remove the three R/L protocols from the software
• discard the associated R/L overlays.

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)

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:

• Anaesthetists
• EBME departments
• EEG technicians
• Equipment stores
• General surgery
• Health and safety managers
• Intensive care units
• Medical physics departments
• Neurologists
• Neurosurgeons
• Radiology departments
• Risk managers
• Theatres

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

• Hospitals in the independent sector
• Private medical practitioners

Peter Highmoor
CareFusion
The Crescent
Jays Close
Basingstoke
RG22 4BS

Tel: 01256 388 398
Fax: 01256 388 388

Email: peter.highmoor@carefusion.com 

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