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

	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

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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 (451Kb)

Page last modified: 07 February 2008