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MDA/2007/026 - External defibrillators: Samaritan AED manufactured by HeartSine. Models SAM001, SAM002 and SAM003

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/026
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 20 March 2007 at 14:00
Ref: MDA/2007/026


 

 Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
External defibrillators: Samaritan AED manufactured by HeartSine.  Models SAM001, SAM002 and SAM003.		  
Problem:
In semi-automatic mode the device incorrectly recognises an unusual ECG rhythm.  The rhythm is non-shockable but the device can advise to shock.
The manufacturer has advised users not to use these devices in automatic modes until the software has been updated.
A copy of the manufacturer’s advisory notice is on the field safety notice section of the agency’s website.

 
Action by:
All engineering and clinical staff involved in the use or maintenance of these devices.		  

Action:

  • Identify whether your organisation has any of the above devices.
  • SAM002 and SAM003 models should be withdrawn from use and quarantined.
  • Ensure that users are aware that SAM001 models should only be used in manual mode.
  • Contact HeartSine Technologies (tel: 028 9093 9400) to arrange for a software update.  After the update has been carried out the devices can be returned to unrestricted use in automatic mode. 
 

Distributed to:

NHS trusts in England
Commission for Social Care Inspection (CSCI)		 - Chief Executives*
– Headquarters
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 CSCI and Healthcare Commission.

>Page 2


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 27 March 2007
Deadline (action complete): 10 April 2007

 

Page last modified: 20 March 2007