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Contoura 880 Beds

Notice type: Advisory

Date: 21/08/2009

  

Product name or type:
Contoura 880 Beds

Manufacturer Or Supplier:
Huntleigh Healthcare Ltd

Target Audience:
Health Board CEOs, 
Community Care Managers, 
Community Therapists, 
Health Visitors, 
Carers of the Elderly, 
Risk Managers, 
Loan Store Managers, 
Children’s Disability Services, 
Special Schools, 
Educational Establishments

Problem Or Issue:
Some bed rail support brackets have been found to have poor welds causing them to fail in use. Patients are at risk of injury from a fall if the bed rails fail in use.

Background Information Or Related Documents:
In May 2007, Huntleigh Healthcare Limited in conjunction with the MHRA issued an MDA alert (MDA/2007/041) http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON2031264in relation to their Contoura 880 beds manufactured between December 1999 and June 2001 with serial numbers in the range 167386 to 382938. 
The issue with the device is that some of the bed rail support brackets have been found to have poor welds causing them to fail in use. Patients are at risk of injury from a fall if the bed rails fail in use. The mounting brackets that connect the bed rails to the bed frame are beneath the mattress platform. 
The IMB is aware that several of these beds were placed on the market in Ireland, and while some customers who have these beds may have received the MDA alert that was circulated by the MHRA, the IMB is issuing this safety notice to ensure all Contoura 880 customers are aware of the issue 

Contoura 880 Beds Document

Actions To Be Taken:
1) Ensure the appropriate personnel are made aware of this notice. 

2) Identify the location of all Contoura 880 beds. 

3) Determine if your institution has devices affected by this issue. 
This can be determined by: 
     A) Checking the manufacturing date to see if it is between December 1999 and June 2001. 
     B) Checking if the Serial number lies in the range 167386 to 382938. 

4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge. 

5) Ensure that correction is completed on all affected devices.

Further Information:
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

Enquiries to the manufacturer should be addressed to: 

Arjo (Ireland) Limited 
EA House 
Damastown Industrial Park 
Mulhuddart 
Dublin 15 

Telephone: 01 809 8960 
Fax: 01 809 8961 
Email: dublin@arjo.ie 

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