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MDA/2006/068 - Physiological monitor: Smiths Medical 3404 BCI® AUTOCORR® Plus pulse oximeter/ECG/respiration monitor

Document details:

Type: Medical Device Alert
Series No: n/a
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 13 December 2006 at 15:00
Ref: MDA/2006/068

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


 

Device:
Physiological monitor: Smiths Medical 3404 BCI® AUTOCORR® Plus pulse oximeter/ECG/respiration monitor.

>Page 2

Problem:
Noisy or no display of SpO2, ECG or respiration readings. This is due to a faulty component in a known group of devices.

>Page 2

Action by:
Anaesthetists, operating theatre practitioners, intensive care, A&E, ambulance and technical staff.
 

Action:
Ensure you have received the Safety Action Bulletin 06-SAB07 from Smiths Medical (see appendix).

  • Identify and quarantine devices with serial numbers as listed overleaf in the device section.
  • Contact Smiths Medical to have any affected monitors repaired.

 

Distributed to:

 
NHS trusts in England
Healthcare Commission (CHAI)
– Chief Executives*
– 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 3

Appendix:
Smiths Medical Safety Action Bulletin (in pdf only).

>Pages 4-6



 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 28 December 2006
Deadline (action complete): 15 January 2007


Page last modified: 18 December 2006