Medical Device Alert: TruSat Pulse Oximeter manufactured by GE Healthcare (formerly Datex-Ohmeda) (MDA/2010/055)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/055 or 2010/005/012/291/010.

Technical aspects
Mr J Lefever or Dr C Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3262 / 3219
Fax: 020 7084 3209

Email: jim.lefever@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mr Jonathan Plumb
Medicines and 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).

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

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

Possibility of excessive leakage current resulting in abnormal heart rhythm or burns.

There is a potential electrical safety risk to the user when the device is running on the external power supply and the power supply connector is damaged or improperly connected on the TruSat.

The manufacturer published a Field Safety Notice covering this issue on 2 June 2010, but has not received confirmation of its receipt from all customers.

• Identify all affected TruSat pulse oximeters.
• Contact GE to arrange for the return of the power supplies for free replacements.
• Do not connect the TruSat pulse oximeter to a patient whilst charging the unit from the external power supply unless a separate isolation transformer is connected between the power supply and the mains supply.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• Health Protection Agency (HPA) (directors)
• 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 departments
• All wards
• Ambulance staff
• Biomedical engineering staff
• EBME departments
• Health and safety managers
• Intensive care nursing staff (adult)
• Intensive care nursing staff (paediatric)
• Medical directors
• Nursing executive directors
• Operating theatre practitioners
• Risk managers
• Theatres

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

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Clinics
• Domiciliary care providers
• Hospices
• 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 hospitals
• Equipment libraries and stores
• General practitioners
• Maintenance staff
• Palliative care team
• Walk-in centres

Mr Paul Mardle or Mr Max Norwood
GE Healthcare
71 Great North Road
Hatfield
AL9 5EN

Tel: 01707 263 570
Fax: 01707 260 065

Email: paul.mardle@ge.com or max.norwood@ge.com