Notice Information: - Advisory - 21/03/2012

Title:

Invacare Mobility Powerchairs Control Systems

Product:

Invacare Mobility Powerchairs Control Systems

Reference:

SN2012(02)

Manufacturer / 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

Issue:

Invacare issued a field safety notice (FSN) highlighting to users of Invacare mobility powerchairs that the integration of a replacement joystick or power module into a wheelchair or the reprogramming of the existing joystick or power module by someone other than Invacare potentially carries a risk as the functionality and performance of the wheelchair may not conform with the specification as originally supplied.

Background Information / Related Documents:

Invacare utilises joystick or power modules that are designed and configured for each particular wheelchair model. Any person intending to replace or reprogramme any joystick or power module for an existing user must first:

• Obtain full details of the original configuration and programming of the wheelchair from Invacare
• Check with Invacare that the proposed replacement equipment will be compatible

Invacare circulated their field safety notice, FSN036, to the Irish market in January 2011. Invacare have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.

Action to be taken:

The IMB advises that users ensure the appropriate personnel are made aware of this notice and follow the manufacturer’s recommendations in the attached field safety notice.

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:

Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@imb.ie
Website: www.imb.ie

Click here to download PDF Version of Safety Notice

Click here to download Field Safety Notice