My HPRA: Register

Quickie Neon Swing-Away Wheelchairs

Notice type: Advisory

Date: 09/12/2011

  

Product name or type:
Quickie Neon Swing-Away Wheelchairs

Reference:
SN2011(32)

Manufacturer Or Supplier:
Sunrise Medical

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:
It has come to Sunrise Medical’s attention through post-market surveillance activities that a small number of upper frame tubes that support the backrest have failed on the Quickie Neon Swing-Away wheelchair. There is the potential for frames to fail and users could potentially fall backwards resulting in serious injury.

Background Information Or Related Documents:
An upgrade kit is available from Sunrise Medical through MMS Medical Limited to address this potential failure of the upper frame tubes. As outlined in the attached field safety notice (FSN), this corrective action only affects the following wheelchairs: 

• Neon Swing-Away models 
• With seat depth up to 44cm (chairs above this seat depth are not affected) 
• Manufactured before June 2010 (wheelchairs made after this date have a strengthened upper frame tube) 

All relevant information relating to this upgrade can be found in the attached FSN, issued by Sunrise Medical in February 2011. 

Sunrise Medical and their distributor MMS Medical have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are approximately 38 Quickie Neon Swing-Away wheelchairs on the Irish market, which require an upgrade kit from MMS Medical Limited to be fitted.

Quickie Neon Swing-Away 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, please follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that the corrective action is completed on all affected medical devices. 

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

Rose Gilbert 
MMS Medical Limited 
51 Eastgate Drive 
Little Island 
Cork 

Telephone: 021-4618000 
Fax: 021-4618099 
Email: info@mmsmedical.ie 

Enquiries to the manufacturer should be addressed to: 

Jeremy Fletcher 
Sunrise Medical 
Wollaston 
Stourbridge 
West Midlands DY8 4PS 
United Kingdom 

Telephone: +44-1384-446672 
Email: jeremy.fletcher@sunmed.co.uk 

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 

Please click here to download the field safety notice.

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

« Back