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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
Reference:
SN2011(31)
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
Carers
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
www.invacare.co.uk
.
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
Swords
Co. Dublin
Telephone: 01-8107084
Fax: 01-8107085
Email:
nharvey@invacare.com
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
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Click here to upload a PDF version of this Safety Notice
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Date Printed: 25/04/2024