Medical Device Alert: GE Healthcare Anaesthetic CareStations (MDA/2009/026)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/026 or 2009/002/017/601/001

Technical aspects
Mr Douglas McIvor or Mr Andrew Monson
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3193/3241
Fax: 020 7084 3209
E-mail: douglas.mcIvor@mhra.gsi.gov.uk
andrew.monson@mhra.gsi.gov.uk

Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3123
Fax: 020 7084 3111
E-mail: susanne.ludgate@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

An intermittent electrical connection with the On/standby switch can cause the machine to shutdown unexpectedly. The machine alarms and then a message appears on screen stating ‘System Shutdown in 8 seconds’.

• Identify affected machines and contact GE Healthcare who will replace On/standby switches.
• Ensure all users are aware of and follow the recommendations in the attached Field Safety Notice.
• Ensure manual/back-up ventilation is always available e.g. a self-inflating bag and oxygen cylinder.
• Ensure that all users are aware that for the Aisys machine only, if the machine is not able to be re-booted, anaesthetic agent delivery may stop and alternative sedation may be required.

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)

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
• A&E directors
• Anaesthetists
• Day surgery units
• Dental departments
• EBME departments
• Health and safety managers
• Maternity units
• Medical directors
• MRI units, directors of
• Outpatient theatre managers
• Perioperative practitioners
• Risk managers
• Theatre managers

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

• Hospitals in the independent sector
• Independent treatment centres
  

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

Manufacturer
Mr Paul Mardle
QRS Office
71 Great North Road
Hatfield
Hertfordshire
AL9 5EN
Tel: 01707 263 570 x 1402520
Fax: 01707 260 065
E-mail: paul.mardle@med.ge.com

UK Technical Support
Tel: 01707 263570
E-mail: askuktechnicalsupport@ge.com