Medical Device Alert: Action 3 and Action 4 manual wheelchairs manufactured by Invacare (MDA/2010/004)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/004 or 2007/010/005/401/005 or 2006/008/029/301/003 or 2009/001/020/301/002 or 2007/006/018/061/029.

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:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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 3505 / 3922

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

Invacare has revised the instructions for use for various safety related aspects.

Users who are unaware of these revised instructions are at risk of injury. In particular, from a fall due to instability or from positional asphyxiation due to poor lap belt position, fitting or adjustment.

The MHRA is aware of several reports relating to different aspects of the Action 3 and Action 4 wheelchairs. Injuries have been reported in relation to some of these issues. Invacare has revised the content of the instructions for use (IFU) for these models but has not provided them to all existing users. There is potential for serious injury to users or others if the revised IFU are not adhered to.

The Action 3 and Action 4 IFU have now been updated with the following additions:

• Information on the correct fitting and adjustment of the tension-adjustable (contour) back rest upholstery.
• Clarification on the set-up and configuration of the seat and rear wheel position.
• Information on the need for and the use of a back brace for those wheelchairs with reclining back rests and/or tension-adjustable upholstery.
• The correct fitting, use and method of adjustment of the various types of lap belts supplied with these wheelchairs.
• A five year intended life cycle for these wheelchairs has been added.
• Wheelchairs fitted with Comfort seating are not presently suitable for use as a seat in transport even though these wheelchairs were supplied with tie-down labels on the wheelchair frame (Invacare is working towards modifying these wheelchairs to allow use as a seat in a vehicle but have not yet been able to provide adequate detail or a date when it will be available).

The updated IFU for both models are available from Invacare UK or can be downloaded from the Invacare website (external link).

Invacare has already produced one Field Safety Notice (FSN 020) concerning the removal of tie-down labels on Action 3 wheelchairs. Invacare has also agreed to issue further Field Safety Notices for the Action 3 and Action 4 to cover the additional items shown above, but has not yet provided issue dates for these.

• Trace all affected wheelchairs.
• Ensure users receive a copy of the revised instructions for use.
• Review the revised instructions for use to ensure that the wheelchairs are still appropriate for the existing users’ needs.
• For affected wheelchairs fitted with a Comfort seating system, remove the tiedown labels from the frame.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• OFSTED
• 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:

• Ambulance services directors
• Consultants in rehabilitation medicine or special seating
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Patient transport managers
• 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 (adults)
• Care homes providing personal care (adults)
• Further education colleges registered as care homes
• Hospices
• Hospitals in the independent sector
• Transport managers for wheelchair users

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

• Educational establishments with facilities for wheelchair users
• Residential special schools
• Wheelchair accessible school transport managers

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
• Patient transport managers
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair and seating service managers

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

• Day centres
• Equipment store managers
• Maintenance staff and contractors
• Occupational therapists
• Risk managers
• Transport managers for wheelchair users
• 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