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/2007/085 - Automatic external defibrillator - Welch Allyn AED 20

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2007/085
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Related information:

MHRA pages:

Page 1

Issued: 07 November 2007 at 14:00
Ref: MDA/2007/085

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request

Device:
Automatic external defibrillator - Welch Allyn AED 20.

>Page 2

Problem:
Failure to defibrillate. The manufacturer is recalling a specific batch of these defibrillators to correct a malfunction that prevents or delays the delivery of therapy, which can lead to failure to resuscitate a patient.
This recall is in addition to a batch of AED 20 defibrillators recalled in July 2006 to correct a similar malfunction (MDA/2006/047).

>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:

  • Identify affected devices using the list of serial numbers in the appendix.
  • Contact the manufacturer to arrange service and upgrade as soon as possible.
  • Consider if it is appropriate to substitute alternative defibrillators for those affected devices that are in service but are awaiting upgrade.
  • If affected devices awaiting upgrade are used and display a ‘Defib Comm’ error message, the manufacturer has advised that switching the device off and then on again may clear the error message.
  • The equipment maintenance records should be updated when upgraded units are returned.
  

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:
Serial numbers of affected devices (in pdf only).

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 21 November 2007
Deadline (action complete): 07 December 2007


Page last modified: 07 November 2007