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MDA/2007/095 - External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/095
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 06 December 2007 at 14:30
Ref: MDA/2007/095

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd.

>Page 2

Problem:
Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off.

>Page 2

Action by:
Electro–biomedical engineering (EBME) departments.
All clinical staff managing patients supported by affected devices.		  

Action:

  • Check that the rapid pace switch is turned off before shutting down the device.
  • Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade.
  • Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* 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): 17 December 2007
Deadline (action complete): 06 June 2008

 

Page last modified: 06 December 2007