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MDA/2007/005 - Inditherm OTM1, OTM2, GTM1, RB1 & OTB1 operating theatre blankets and mattresses

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/005
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 17 January 2007 at 11:00
Ref: MDA/2007/005

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Inditherm OTM1, OTM2, GTM1, RB1 & OTB1 operating theatre blankets and mattresses, used for maintaining patients’ body temperature.		  
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.		  
Action by:
All those involved in the purchase, use or maintenance of these devices.		  

Action:

  • Identify all of the above devices and contact Inditherm (tel: 01709 761000) to arrange for an upgrade.
  • Inspect the devices and if there are signs of folding, or if you are in any doubt, remove from use and seek advice from Inditherm.
  • Ensure that these devices are stored flat or loosely rolled, but not folded
  

Distributed to:

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

* 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.

>Page 2

Appendix:
Manufacturer’s advisory notice.

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 24 January 2007
Deadline (action complete): 07 February 2007


Page last modified: 17 January 2007