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MDA/2007/093 - Paediatric respiratory support device - Infant Flow® SiPAP™ manufactured by Viasys Healthcare

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/093
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: 05 December 2007 at 14:30
Ref: MDA/2007/093


 
Immediate action
Tick mark
Action
 
Update
 
Information request

 

Device:
Paediatric respiratory support device - Infant Flow® SiPAP™ manufactured by Viasys Healthcare.

>Page 2

Problem:
There has been an important change to the operator manual that needs to be communicated to end users.

>Page 2

Action by:
Neonatal and pediatric intensive care departments and those responsible for the management of these flow driver devices.		  

Action:

 

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.

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 27 December 2007
Deadline (action complete): 15 January 2008

Page last modified: 07 February 2008