Birdie Patient Lifters

Notice type: Advisory

Date: 01/12/2011

 

Product name or type:
Birdie Patient Lifters


Reference:
SN2011(30)


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:
It has come to Invacare’s attention that the countersunk head screws in the base of the Birdie lifter could potentially come loose. This can lead to breakage of the screw. If the screw breaks, the ‘leg’ of the base can detach and lead to a collapse of the lifter which may result in injury to the user.


Background Information Or Related Documents:
Invacare recommends that users inspect their Birdie Lifter to ensure that the four screws are secure. Instructions on the inspection procedure are provided in the attached field safety notice issued by Invacare on the 20th August 2009. If the screws are not tight enough, you should remove the lifter from use and contact your local Invacare sales office. Invacare will replace affected bases with new bases. 

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 25 Birdie Lifters on the Irish market, which require an inspection and possible upgrade.

Birdie 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 
Unit 5, Westpoint Buildings 
Westpoint Business Park 
Ballincollig 
Cork 

Telephone: 021-4875055 
Fax: 021-4860525 
Email: enquiries@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: vigilance@imb.ie 
Website: www.hpra.ie 

Please click here to download a PDF copy of the Safety Notice

Please click here to download the Field Safety Notice


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