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Invacare Mobility Powerchairs Control Systems
Notice type:
Advisory
Date:
21/03/2012
Product name or type:
Invacare Mobility Powerchairs Control Systems
Reference:
SN2012(02)
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:
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 Or 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.
Invacare Mobility Powerchairs Control Systems Document
Actions 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:
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 download PDF Version of Safety Notice
Click here to download Field Safety Notice
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Date Printed: 19/04/2024