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MDA/2007/025 - Patient monitoring system: ApexPro/ApexPro CH telemetry system manufactured by GE Healthcare

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/025
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 19 March 2007 at 15:00
Ref: MDA/2007/025


 
Immediate action
 Tick mark 
Action
 
Update
 
Information request


Device:
Patient monitoring system: ApexPro/ApexPro CH telemetry system manufactured by GE Healthcare.

>Page 2

Problem:
Possibility of no visual or audible system failure alarms.

>Page 2

Action by:
Cardiac care staff, intensive care staff and technical staff.		  

Action:

  • Ensure you have received the urgent medical device correction notice from GE (see appendix in pdf only).
  • Ensure the ST monitoring default system is enabled at both the CIC and individual patient monitors and follow the advice in the GE letter regarding their continued use until the upgrade is complete (short term recommendation).
  • Ensure that arrangements are made to upgrade the software to remove this problem.
 

 

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

Appendix:
GE urgent medical device correction (in pdf only).		  

 >Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 April 2007
Deadline (action complete): 15 May 2007


Page last modified: 19 March 2007