Medical Device Alert: Atlantic bed rails, product code EBA013, manufactured by Park House Healthcare Ltd (MDA/2010/080)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/080 or 2010/005/019/301/002.

Please note that the telephone number for the MHRA contact below will change on 25 October 2010. From that date please contact the MHRA Central Enquiry Point on 020 3080 6000 and ask for the person by name.

Technical aspects
Brian Mather or David Small
Medicines & 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

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
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
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

The original instructions for use issued with these bed rails contained insufficient information for correct installation. If incorrectly fitted there is a risk of entrapment between the bed rail and the head or foot board of the bed, resulting in postural asphyxiation.

Park House Healthcare has issued a Field Safety Notice, but is unable to trace all bed rails.

• Trace all Atlantic bed rails.
• Obtain a copy of the revised instructions for use (IFU) from Park House Healthcare.
• Ensure that the bed rails are installed and used in accordance with the revised IFU (Revision 5, dated 5 October 2010) and that the gap between the vertical rail and the head board is less than 60 mm.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• 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)
• Social services in England (directors)

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:

• All wards
• Equipment store managers
• Health and safety managers
• Maintenance staff and contractors
• Occupational therapists
• Nurses
• Nursing directors
• Risk managers

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

• 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

OFSTED to:
The MHRA considers this to be important to:

• Educational establishments with beds for children
• Residential special schools

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

• Community hospitals
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Nurses
• Risk managers

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

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

Roy Smith
Park House Healthcare Ltd
Whitehall 26 Business Park
1 Heathfield Lane
Birkenshaw
BD11 2HW

Tel: 0845 0600 333
Fax: 0845 0600 334
Email: roy.smith@parkhouse-hc.com