Medical Device Alert: Rea Assist wheelchairs manufactured by Invacare Rea AB (MDA/2009/061)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/061 or 2009/001/020/401/015.

Ed Ball or James Mcveigh
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 Central Alerting System website (external link).

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:

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 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

Due to an ineffective locking mechanism the backrest may suddenly detach and cause the user to fall from the wheelchair, resulting in serious injury.

Invacare Rea AB has identified a problem with a batch of wheelchairs. Some of the batch has ineffective locking mechanisms where the push handle/backrest attaches to the frame. The backrest may suddenly detach from the wheelchair whilst manoeuvring, particularly up or down steps. The problem can be identified by detailed inspection (see appendix). To rectify the problem replacement parts are now available from Invacare UK.

• Trace all Rea Assist wheelchairs with a serial number in the range 020808103710 to 020808819831 inclusive.
• Inspect the lower backrest frame and check the alignment of the locking mechanism with the required indent (see appendix).
• Where the indent is missing or misaligned contact Invacare to arrange replacement of the affected parts.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• Health Protection Agency (HPA) (Directors)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• NHS Boards and Trusts in Wales (Chief Executives)
• OFSTED (Directors of Children’s Services)
• 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:

• Consultants in rehabilitation medicine/special seating
• Equipment store managers
• Health and safety managers
• Maintenance staff and contractors
• Occupational therapists
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair and seating service managers

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

• Care homes providing nursing care
• Hospices

OFSTED to:
Directors of children’s services for onward distribution to:

• Educational establishments with facilities for wheelchair users
• 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
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair service managers

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

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Risk managers
• Wheelchair and seating service managers

Technical Services Department
Invacare UK Operations Ltd
South Road
Bridgend Industrial Estate
Bridgend
CF31 3PY

Tel: 01656 647 327
Fax: 01656 753 299

Email: UK@invacare.com