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G&S Smirthwaite Samba Chair

Notice type: Advisory

Date: 23/04/2012

  

Product name or type:
G&S Smirthwaite Samba Chair

Reference:
SN2012(04)

Manufacturer Or Supplier:
G&S Smirthwaite Ltd.

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:
G&S Smirthwaite Ltd. issued a field safety notice (FSN) highlighting to users of the Samba Chair that for certain product code / serial number combinations, the lever operating the chair ‘Tilt in Space’ function (TIS) may not freely engage into the notch in the safety catch. The Irish Medicines Board (IMB) is aware that there has been difficulty in locating all devices in Ireland affected by this field safety corrective action.

Background Information Or Related Documents:
The safety catch is designed to prevent accidental operation of the TIS lever. The TIS lever is located on the left hand side of the Samba chair and has a red button for identification. The TIS mechanism features a safety catch that is designed to prevent accidental operation of the lever. When the lever is operated and released, it should always return to a ‘park’ position, as shown in the attached FSN. 

The FSN for this issue, TB 2011-2/1, was circulated to the Irish market by O’Neill Healthcare in March 2011. O’Neill Healthcare is no longer the distributor for this product in Ireland and all queries relating to this action should be addressed to G&S Smirthwaite Ltd. 

G&S Smirthwaite Samba Chair Document

Actions To Be Taken:
The IMB advises that users ensure the appropriate personnel are made aware of this notice and follow the manufacturer’s recommendations in the attached FSN.

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

Mr. Richard Snape 
G&S Smirthwaite Ltd. 
17 Wentworth Road 
Heathfield 
Newton Abbot 
Devon, England 
TQ12 6TL 

Telephone: +44 1626 835552 
Email: enquiries@smirthwaite.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 a PDF version of this Safety Notice

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

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