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MDA/2008/039 - Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with certain settings

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/039
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 16 June 2008 at 11:30
Ref: MDA/2008/039

 

 Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with certain settings.

>Page 2

Problem:
When used in AED mode with ‘Auto Analyze’ ON, the ECG analysis (Shock Advisory System™) may start before warning is given to the user to stand clear of the patient. This can result in inappropriate shock or no shock recommendations being made by the device due to CPR or movement artefacts.

 
Action by:
All those involved in the use or maintenance of these devices.

 

Action:

  • Identify affected devices – refer to the details given on page 2.
  • If AED mode is used the ‘Auto Analyze’ function should be set to OFF or ‘After First Shock’ (see appendix).
  • Ensure that all users are aware of the change in operation of the device – the ‘ANALYZE’ button must be pressed.

 >Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
NHS Boards in Scotland - Chief Executives


 * via CE Bulletin

>Page 2 
Contacts:
Details of manufacturer contacts and contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Page 3

Appendix:
Instructions for changing ‘Auto Analyze’ setup options (in pdf only).

>Pages 5-6 


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 23 June 2008
Deadline (action complete): 07 July 2008

 

 

Page last modified: 16 June 2008