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Linet Eleganza Standard and Deluxe Model Bedframes

Notice type: Advisory

Date: 12/08/2011

  

Product name or type:
Linet Eleganza Standard and Deluxe Model Bedframes

Reference:
SN2011(20)

Manufacturer Or Supplier:
Linet Spol s.r.o. Czech Republic

Target Audience:
Hospital Managers / CEOs 
Clinical Directors 
Risk Managers 
Purchasing Managers 
Nursing Managers 
Paediatric Ward Sisters 
Health Services Executive (HSE) 
Public and Private Nursing Homes 
Theatre and Nursing Staff 
Medical Device Distributors 
Clinical / Biomedical Engineers 

Problem Or Issue:
Linet has become aware that certain bedframes are susceptible to developing cracked or damaged welds in one particular area of the bedframe.

Background Information Or Related Documents:
Linet has determined that the fault is related to a sporadic occurrence of cracking or breaking welds connecting the patient surface (frame) to the main lifting column assembly. The two column assemblies are connected to the frame, each by two brackets. The cause of the damage is possible vibration during transport or stressing of the device during possible overloading conditions experienced over time. 

Linet has published a field safety notice (FSN, see attached) and has developed a field modification to address this issue. 

Linet Eleganza Standard and Deluxe Model Bedframes Document

Actions To Be Taken:
Linet has confirmed that this issue is confined to bedframes manufactured up to December 2005 (see FSN for affected serial numbers). To date, Linet has been unable to obtain full traceability for affected devices potentially distributed in Ireland. 

The IMB advises that users: 

• Identify the affected devices in your facility. 
• If you have affected devices, follow the manufacturer’s recommendations, as outlined in the attached FSN, and contact Linet to arrange for modification. 

Further Information:
Enquiries to Linet should be addressed to: 

Rowena King / Richard Westbrook 
Linet UK Service Department 
Linet House 
17 Murrills Estate 
Portchester 
Hampshire 
PO16 9RD 
United Kingdom 

Telephone: +44 2392 322135 / +44 2392 322134 
Fax: +44 2392 389540 
E-mail: rking@linet.uk.com, rwestbrook@linet.uk.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 PDF version of safety notice

Please click here to download PDF version of field safety notice

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