Headrest attachment to operating tables - confirm actions after receipt of field safety notice

(Maquet Ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65A0 and 1002.65S0. (MDA/2011/075)

Device

Medical Device Alert: Headrests attachment to operating tables with connection fixture: 1002.65A0 or 1002.65S0 manufactured by Maquet Ltd (MDA/2011/075) (jpg)

Headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0 manufactured by Maquet Ltd.

Problem

Concerns about the safe use of a headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0.

The manufacturer issued a Field Safety Notice (FSN) for this device on 12 May 2011 (1709Kb) but has not had sufficient confirmation from users that they have received and acted on this information.

This alert has been issued in support of the manufacturer’s actions.

Action

  • Ensure that relevant members of staff are aware of the problem.
  • Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Action by:

Healthcare professionals using these devices.

Distribution

This MDA has been sent to:

  • NHS trusts in England (Chief Executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Equipment Co-ordinators)
  • Local authorities in Scotland (Equipment Co-ordinators)
  • NHS boards and trusts in Wales (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:

  • A&E departments
  • Anaesthetists
  • Biomedical engineering staff
  • Day surgery units
  • EBME departments
  • General surgical units, directors of
  • Maternity units
  • Medical directors
  • Medical physics departments
  • Nursing executive directors
  • Operating theatre practitioners 
  • Outpatient theatre managers
  • Risk managers
  • Surgeons
  • Theatre managers
  • Theatre nurses

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

Colin Moralee
Maquet Ltd

Tel: 0191 519 6200
Fax: 0191 519 6201

Email: cmoralee@maquet.co.uk

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/2011/075 or 2011/005/013/081/001.

Technical aspects

Ian Patterson-Waterston or Andy Marsden
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7261 / 7205
Fax: 020 8754 3965

Email: ian.patterson-waterston@mhra.gsi.gov.uk or andy.marsden@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7128
Fax: 020 8754 3965

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 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:

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

Download documents

Medical Device Alert: Headrests attachment to operating tables manufactured by Maquet Ltd. (MDA/2011/075) (610Kb)

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