Medical Device Alert: Eleganza Standard and Deluxe beds manufactured by Linet prior to December 2005 (MDA/2011/092)


Action

Ref: MDA/2011/092 | Issued: 18 August 2011 at 15:00


Document details:

Type: Medical Device Alert
Series No: MDA/2011/092
Audience: Healthcare professionals
Published: 18 August 2011 at 15:00
Format: Electronic only
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

1. England


If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/092 or 2011/001/018/401/006

Jonathan Smith or David Small
Medicines and Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool FY2 0BR

Tel: 01253 596 000
Fax: 01253 596 177

Email: bav@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 (external link)



2. 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

http://www.dhsspsni.gov.uk/index/hea/niaic.htm



3. 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

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/



4. 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



5. Device


Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds.

Manufactured by Linet prior to December 2005.

Affected serial numbers:
Standard: 1739003 – 20053049650
Deluxe: 1752144 – 20053022252



6. Problem


The manufacturer issued a Field Safety Notice (FSN) for this device on 15 July 2011, but has not had sufficient confirmation from users that they have received and acted on this information.

A copy of the FSN is in the appendix of this alert and it is also available on the MHRA website.

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


7. 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:
All those using, managing and maintaining hospital beds. In particular: nurses, maintenance staff and contractors.

 



8. 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)
  • Health and Safety Executive
  • Primary care trusts in England (Chief Executives)
  • Social services in England (Directors)

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: 

  • All wards and clinical departments
  • EBME departments
  • Equipment store managers
  • Maintenance staff and contractors
  • Medical directors
  • Nursing executive directors
  • Risk managers

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Community hospitals 
  • Community nurses
  • Equipment store managers
  • Maintenance staff and contractors
  • Risk managers

Social services
Liaison officers for onward distribution to all relevant staff including:

  • Care at home staff
  • Equipment store managers
  • Maintenance staff and contractors
  • Risk managers

Independent distribution

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

  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Further education colleges registered as care homes
  • Hospices
  • Hospitals in the independent sector

Please note: CQC 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.

 

 

 



9. Contacts


Supplier
Rowena King
Linet UK Service Department
Linet House
17 Murrills Estate
Portchester
Hampshire PO16 9RD

Tel: 02392 322135
Fax: 02392 389540

Email: rking@linet.uk.com



10. Feedback


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





Page last modified: 18 August 2011