MDA/2007/037 - All paediatric ventilator breathing systems containing a water trap, manufactured by Viasys Healthcare

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Document details:

Type:	Medical Device Alert
Series No:	MDA/2007/037
Audience:	Healthcare professionals
Published:
Format:	Electronic and paper
Size:	A4
Pages:	3
Price:	Free
ISBN/ISSN:
Author:
Copyright:	Crown

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Page 1

Issued: 21 May 2007 at 12:15

Ref: MDA/2007/037

	Immediate action
	Action
	Update
	Information request

Device:
All paediatric ventilator breathing systems containing a water trap, manufactured by Viasys Healthcare.

>Page 2

Problem:
The MHRA has received reports of Viasys auto drain water traps failing to drain accumulated fluid. The manufacturer is investigating these failures. At this time there is no information available as to the extent of this problem, therefore the affected water traps may be found in any Viasys paediatric breathing system. The MHRA is urging caution in the use of these Viasys breathing systems until further information is available.

Action by:
Paediatric and neonatal intensive therapy departments.

Action:

Identify all Viasys paediatric breathing systems containing a water trap.
Consider the use of an alternative breathing system until the scope of the problem is identified.
If an alternative breathing system is not available ensure the manufacturer’s recommended pre-use checks are strictly followed and the water trap’s function is closely monitored during 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): 29 May 2007	Deadline (action complete): 6 June 2007

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MDA/2007/037 - All paediatric ventilator breathing systems containing a water trap, manufactured by Viasys Healthcare (515Kb)

Page last modified: 21 May 2007