Notice Information: - Advisory - 23/04/2012

Title:

G&S Smirthwaite Samba Chair

Product:

G&S Smirthwaite Samba Chair

Reference:

SN2012(04)

Manufacturer / 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

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 / 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.

Action 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:

Irish Medicines Board
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.imb.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