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| Issued: 17 September 2007 at 14:30 |
Ref: MDA/2007/073
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Immediate action |
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Action |
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Update |
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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). |
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| 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. |
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| Action by: Surgeons, theatre managers, operating theatre staff and all those who maintain and service these devices. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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| Appendix: List of serial numbers of affected units (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 24 September 2007
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Deadline (action complete): 08 October 2007
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MDA/2007/073 - Electrosurgery bipolar unit: model TDB 60 manufactured by Eschmann Ltd 
