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MDA/2005/055 - Nellcor N-595 pulse oximeters N-395, NPB-290 and NPB-295 pulse oximeters (with serial numbers after G01844386)

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/055
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/055
Issued: 18 October 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  

 

  Further Information
DEVICE:
Nellcor N-595 pulse oximeters
N-395, NPB-290 and NPB-295 pulse oximeters (with serial numbers after G01844386).		  
PROBLEM:
The failure rate of the loud speaker component in N-595 and some N-395, NPB-290 and NPB-295 pulse oximeters is higher than expected. This may result in the monitor losing its audio alarm. Neither the visual nor remote alarm functions are affected.		  

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ACTION BY:
All nursing and medical personnel using these devices.		  
ACTION:
Users should be aware of this problem and the appropriate action to take, (see Appendix for manufacturer's letter), to test the alarm system and have the corrective action undertaken if required.		  

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DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*

* via CE Bulletin

  

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CONTACTS:
Details of manufacturer contacts, MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI (and Healthcare Commission).		  

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Page last modified: 07 February 2008