In Safety warnings

Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2007/069 - Automatic external defibrillator: Lifepak 500® manufactured by Medtronic Ltd

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2007/069
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 9
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 5 September 2007 at 15:00
Ref: MDA/2007/069


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Automatic external defibrillator: Lifepak 500® manufactured by Medtronic Ltd.		  
Problem:
Under certain conditions the defibrillator may deliver a shock at 100J instead of the manufacturer's minimum default setting of 200J. This problem affects defibrillators with operating software versions of 4.4 or lower.

>Page 2
Action by:
All medical, nursing and paramedical staff, resuscitation training officers, community defibrillation officers and technical staff responsible for the use, maintenance and purchase of these devices.		  

Action:

  • Locate and check Lifepak 500 defibrillators against the list of affected serial numbers (see appendix in pdf only).
  • If you have affected devices, contact the manufacturer for a software upgrade to address this problem.
  • Whilst awaiting the upgrade, users are recommended by Medtronic to operate the defibrillator in ‘fixed’ mode, which is not affected by this problem.
  

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*
Social services in England - Directors*

* 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 CSCI and Healthcare Commission.

>Pages 2-3
Appendix:
List of serial numbers of affected devices (in pdf only).

>Pages 4-9


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 26 September 2007
Deadline (action complete): 31 October 2007


Page last modified: 07 February 2008