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Puma, Beatle, Alex & Ibis XP Power Wheelchairs

Notice type: Advisory

Date: 20/02/2014

  

Product name or type:
Puma, Beatle, Alex & Ibis XP Power Wheelchairs

Reference:
SN2014(04)

Manufacturer Or Supplier:
Handicare, The Netherlands.

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 
Physiotherapists 
Health Visitors 
Carers 
Educational Establishments

Problem Or Issue:
Handicare has identified a potential issue with the compact lights on Puma, Beatle, Alex and Ibis XP power wheelchairs. The lights might cause overheating and as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. Handicare and Healthcare 21 have successfully exchanged 33 units of the 87 placed on the Irish market. There are 54 units in Ireland which cannot be located and require an exchange.

Background Information Or Related Documents:
Handicare is advising users of Puma, Beatle, Alex or Ibis XP power wheelchairs equipped with compact lights to check the lights. Please see the PDF version of this notice for photographs of affected lights. And/or check the unit serial number with the list.  Please see the PDF version of this notice for the list of serial numbers.

If the wheelchair is one of the listed serial numbers or is equipped with compact lights with bulb light or in case of doubt, stop using the front and rear lights until the lights have been replaced. Users can continue to drive their wheelchair and use the blinkers. 

To address this issue, Handicare is replacing the lights in the compact light unit with new LED lights. The action will affect Puma, Beatle, Alex and Ibis XP power wheelchairs equipped with compact light units sold from November 2003 up to and including September 2011. 

This field safety corrective action has been ongoing since November 2011. Handicare and their Irish distributor Healthcare 21 have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are 54 affected power wheelchairs on the Irish market, requiring an exchange, which cannot be located. 

The IMB has not received any complaints in relation to this issue.

Puma, Beatle, Alex Ibis XP Power 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 power wheelchairs. 

3. If you / your institution have any affected power wheelchairs, please stop using the front and rear light (blinkers can still be used) and contact your local dealer or Healthcare 21.

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

Sylvia Stafford 
Unit 5, Westpoint Buildings 
Westpoint Business Park 
Ballincollig 
Cork 

Telephone: 01- 8855551 
Fax: 01- 8855558 
Email: sstafford@hc21.ie 

Enquiries to the manufacturer should be addressed to: 

Ruud Hulsebos 

Handicare B.V. 
Vossenbeemd 104 
5705 CL Helmond 
The Netherlands 

Telephone : +31-492-593888 
Fax : +31-492-537931 
Email : ruud.hulsebos@handicare.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 

Please click here to view a copy of the FSN

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

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