Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure

(Philips) Table will reboot if users attempt a powered and manual movement at the same time. (MDA/2013/045)

CAS deadlines

Action underway: 8 July 2013, action complete: 24 July 2013

Note: These deadlines are for systems to be in place to take actions.

Device

Biplane cardiovascular X-ray system

Biplane cardiovascular X-ray system:

Allura Xper FD10/10.

Manufactured by Philips.

All systems are affected.

Problem

Risk of interruption in treatment/procedure due to an inability to move the table.

The table will reboot if users attempt a powered and manual movement at the same time.

The reboot will take approximately 90 seconds during which time no motorised movement will be possible. This has led to delay during emergency treatment. Basic imaging will be available.

Action

  • Identify affected devices.
  • Inform users of the issue.

Action by

  • Superintendent diagnostic radiographers

Distribution

This MDA has been sent to:  

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS England area teams for information
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. 
Below is a suggested list of recipients.  

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Health and safety managers
  • Medical directors
  • Medical physics departments
  • Radiographer superintendents
  • Radiographers
  • Radiologists
  • Radiology departments
  • Radiology directors
  • Risk managers
  • Vascular surgeons

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Hospitals in the independent sector
  • Independent treatment centres

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Philips Customer Care Service Centre
Philips Healthcare
Philips Centre
Guildford Business Park
Guildford
GU2 8XH
Tel: 0870 532 9741

Email: ph.gxruk.support@philips.com

Feedback

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

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/045 or 2013/001/024/401/008.

Technical aspects

David Grainger or Ann Seeruttun
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7199 or 7161
Fax: 020 8754 3965

Email: david.grainger@mhra.gsi.gov.uk or ann.seeruttun@mhra.gsi.gov.uk

For clinical aspects please contact the MHRA clinical team on 020 3080 7248 or 020 3080 7032.

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 CAS website

Northern Ireland

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

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website

Scotland

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 (IRIC)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922

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

Download documents

Medical Device Alert: Biplane cardiovascular X-ray system manufactured by Philips (MDA/2013/045) (100Kb)

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