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| Issued: 17 January 2007 at 11:00 |
Ref: MDA/2007/005
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Inditherm OTM1, OTM2, GTM1, RB1 & OTB1 operating theatre blankets and mattresses, used for maintaining patients’ body temperature. |
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| Problem: Repeated folding of these devices can cause internal damage to the heating element. This can result in patient burns caused by localised hot-spots. The manufacturer is carrying out a modification which will detect this type of failure. This requires alteration of both the mattress and the control unit. |
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| Action by: All those involved in the purchase, use or maintenance of these devices. |
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Action:
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Distributed to:
* via CE Bulletin |
>Page 2 |
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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. |
>Page 2 |
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| Appendix: Manufacturer’s advisory notice. |
>Page 4 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 24 January 2007
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Deadline (action complete): 07 February 2007
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MDA/2007/005 - Inditherm OTM1, OTM2, GTM1, RB1 & OTB1 operating theatre blankets and mattresses 
