Action 3 and Action 4 Manual Wheelchairs

Notice type: Advisory

Date: 08/12/2011


Product name or type:
Action 3 and Action 4 Manual Wheelchairs


Manufacturer Or Supplier:
Invacare Ireland Limited

Target Audience:
General public 
Hospital CEOs 
Risk Managers 
Procurement Managers 
Loan Store Managers 
HSE Offices 
Community Care Centres 
Occupational Therapists 
Community Care Managers 
Community Therapists 
Health Visitors 
Educational Establishments 

Problem Or Issue:
In January 2010, Invacare revised the instructions for use for Action 3 and Action 4 manual wheelchairs for various safety related aspects.

Background Information Or Related Documents:
Invacare has revised the content of the instructions for use (IFU) for Action 3 and Action 4 manual wheelchairs. There is potential for serious injury if the revised IFU are not adhered to. The Action 3 and Action 4 manual wheelchair IFU have been updated to include the following information:

• 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. 

The updated IFU for both models are available from Invacare Ireland Limited or can be downloaded from the company’s website

Invacare circulated a MHRA medical device alert MDA/2010/004 to the Irish market notifying users of these safety updates. This medical device alert was also circulated by the IMB to Irish healthcare professionals in January 2010. 

Invacare have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are approximately 990 Action 3 and Action 4 manual wheelchairs on the Irish market, which may not have received notification of these updates to the IFU.

Action 3 and Action 4 Manual Wheelchairs Document

Actions To Be Taken:
The IMB advises that users: 

1. Ensure the appropriate personnel are made aware of this notice. 

2. Ensure users receive a copy of the revised IFU.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Neil Harvey 
Invacare Ireland Limited 
5 Seatown Business Campus 
Seatown Road 
Co. Dublin 

Telephone: 01-8107084 
Fax: 01-8107085 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
Click here to upload a PDF version of this Safety Notice

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