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Action® 2000 Manual Wheelchairs

Notice type: Advisory

Date: 24/11/2011

  

Product name or type:
Action® 2000 Manual Wheelchairs

Reference:
SN2011(28)

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 August 2007, Invacare changed the method of mounting the castor assembly to the sideframe. The thread length on the bolts used to mount the castors were found to be insufficient to guarantee that the bolts can be correctly tightened. Loose bolts could potentially cause the sudden failure of one or both of the castor housing bolts, and the possibility of a fall from the wheelchair which could result in injury to the user.

Background Information Or Related Documents:
Invacare are recommending that the castor mounting bolts on all wheelchairs within the affected range are changed. The serial numbers for wheelchairs affected by this issue are 7007533957 (manufacturing date: 4th August 2007) to 7008568013 (manufacturing date: 30th August 2008). Wheelchairs manufactured after the 1st September 2008 are not affected. All relevant information relating to this upgrade can be found in the attached field safety notice, FSN015, issued by Invacare on the 12th January 2009. 

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 64 Action® 2000 manual wheelchairs on the Irish market, where this upgrade is outstanding. 

Action® 2000 Manual Wheelchairs Document

Actions To Be Taken:
The IMB advises that users: 

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

2. Identify the location of all affected wheelchairs. 

3. If you / your institution have affected wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

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: vigilance@imb.ie 
Website: www.hpra.ie 

Please click here to download a PDF version of this Safety Notice

Please click here to dowload a copy of the Field Safety Notice

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