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MDA/2006/002 - Fisher and Paykel Healthcare adult breathing circuits - dual heated: Model numbers RT100, RT104, RT200, RT204, RT026 and 900MR914. Batch numbers 041101 to 050331

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/006
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 12 January 2006 at 15:00
Ref: MDA/2006/002

 

Tick mark
IMMEDIATE ACTION
 
ACTION
 
UPDATE
 
INFORMATION REQUEST


DEVICE:
Fisher and Paykel Healthcare adult breathing circuits - dual heated:
Model numbers RT100, RT104, RT200, RT204, RT026 and 900MR914.
Batch numbers 041101 to 050331.		  >Page 2
PROBLEM:
Risk of fire and burns with specific batches of breathing circuits.		  >Page 2
ACTION BY:
Intensive care staff, theatre staff and staff responsible for purchasing.		  

ACTION:

  • Identify and destroy all affected batches of Fisher and Paykel Healthcare dual heated, adult breathing circuits (041101 to 050331).
  • Contact Fisher and Paykel Healthcare to confirm action and arrange for free-of-charge replacements.
  • In circumstances where these batches are the only available source of heated breathing circuits, make every effort to obtain replacements from Fisher and Paykel Healthcare as soon as possible.
  • Be aware that Fisher and Paykel Healthcare are introducing a label change to these products, recommending a maximum of seven days use.
  

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


ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Deadline (Action underway): 19 January 2006
Deadline (Action complete): 02 February 2006


Page last modified: 07 February 2008