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Birdie & Flamingo Patient Lifters

Notice type: Advisory

Date: 17/09/2013

  

Product name or type:
Birdie & Flamingo Patient Lifters

Reference:
SN2013(11)

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 have been made aware of several incidents involving the carabiner fitted to Birdie and Flamingo lifters.

Background Information Or Related Documents:
There are two issues relating to the carabiner, as follows: 

(1) The carabiner used to attach the spreader bar to the lifter, may show some wear in cases of intensive / severe use. 

(2) Under certain conditions, the spreader bar may unintentionally unhook from the carabiner. 

To address these issues, an upgrade is required to be completed for affected Birdie and Flamingo lifters. Full details of the corrective action can be found in the attached field safety notice issued by Invacare. 

Invacare 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 approximately 184 Birdie & Flamingo lifters on the Irish market, which require upgrade.

Birdie Flamingo Patient Lifters 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 lifters 

3. If you / your institution have affected lifters 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 distributor should be addressed to: 

Sylvia Stafford 
Healthcare 21 
Unit 5, Westpoint Buildings 
Westpoint Business Park 
Ballincollig 
Cork 

Telephone: 021-4860521 
Fax: 021-4860525 
Email: sstafford@hc21.ie 

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

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

Please click here to view the Field Safety Notice

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