Medical Device Alert: GE Fluoro uninterruptible power supply units (UPS) 20KVA associated with Innova cardiovascular X-ray imaging systems (MDA/2009/085)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/085 or 2009/008/026/291/012.

Technical aspects 
Paul Sandhu or David Grainger
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3266/3199
Fax: 020 7084 3209

Email: mailto:paul.sandhu@mhra.gsi.gov.uk or mailto:david.grainger@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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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).

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

Tel: 029 2082 3505 / 3922

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

The UPS battery can degrade and its life expectancy may be shortened, potentially causing the UPS to become unavailable.

This may result in sudden curtailment of examinations with serious consequences for patient diagnosis or treatment.

The GE Fluoro 20 KVA uninterruptible power supply is used to maintain fluoroscopy availability for approximately five minutes in the event of a mains power failure. A UPS battery failure may lead to a total loss of X-ray imaging if the hospital power supply fails. This may result in system unavailability during an interventional examination. GE issued a Field Safety Notice on this problem in September 2009.

• Identify affected devices.
• Verify the battery level is adequate and check if the audible alarm is sounding from the UPS front panel.
• Contact GE either to report any malfunction or to arrange a further inspection visit if no problem is found.
• Ensure that all users and maintenance staff are made aware of this problem.
• Ensure that there is a system in place to check the Fluoro UPS functionality monthly by turning off the mains power input and ensuring that fluoroscopy remains available.

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)
• 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:

• Cardiac laboratory technicians
• Directors of radiology
• Medical directors
• Radiation and medical oncology departments
• Radiologists
• Radiology departments
• Risk managers
• Superintendent radiographers

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

• Hospitals in the independent sector
• Independent treatment centres

Severine Leycuras
Modality Leader
GE Healthcare
352 Buckingham Avenue
Slough
SL1 4ER

Tel: 07920 821 576
Email: severine.leycuras1@med.ge.com

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