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/2007/030 - External defibrillator: Lifepak 20 defibrillator manufactured by Medtronic

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2007/030
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Page 1

Issued: 03 April 2007 at 11:00
Ref: MDA/2007/030

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request

 

Device:
External defibrillator: Lifepak 20 defibrillator manufactured by Medtronic.		  

Problem:
Some Lifepak 20 defibrillators may fail to deliver therapy (see appendix for list of serial numbers of affected devices - in pdf only).

Once mains power is disconnected the defibrillators may not turn on with battery power. The display is blank and all indicator lights are off.

>Page 2

Action by:
Resuscitation officers, clinical staff and all those who maintain and service these devices.		  

Action:

  • Locate and check Lifepak 20 defibrillators against the list of serial numbers (see appendix).
  • If you have affected devices, contact the manufacturer for a software upgrade to address this problem.
  • Whilst awaiting upgrade users should:
    1. turn on the Lifepak 20 defibrillator before unplugging it from the mains
    2. immediately reconnect it to the mains to restore normal operation if the device fails to work with battery power.
  

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

Appendix:
List of serial numbers of affected devices (in pdf only)

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 17 April 2007
Deadline (action complete): 15 May 2007


Page last modified: 07 February 2008