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MDA/2007/073 - Electrosurgery bipolar unit: model TDB 60 manufactured by Eschmann Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/073
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 17 September 2007 at 14:30
Ref: MDA/2007/073


Tick mark 
Immediate action
 
Action
 
Update
 
Information request


Device:
Electrosurgery bipolar unit: model TDB 60 manufactured by Eschmann Ltd (serial numbers with the last six digits from 5D 1201 to 7D-1273 inclusive are affected - see appendix for full list of serial numbers).

 
Problem:
Failure of a component in the main control board may lead to the power output being up to four times that displayed on the front panel. As a precautionary measure, Eschmann are changing the main control board of affected units.		  

>Page 2

Action by:
Surgeons, theatre managers, operating theatre staff and all those who maintain and service these devices.		  

Action:

  • Locate and check TDB 60 units against the list of serial numbers (see appendix).
  • If you have an affected unit, check that the manufacturer has changed the main control board. If not, contact Eschmann to arrange fitting.
  • Ensure that users of affected devices are aware of this potential problem.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3

Appendix:
List of serial numbers of affected units (in pdf only).

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 24 September 2007
Deadline (action complete): 08 October 2007


Page last modified: 17 September 2007