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MDA/2007/013 - Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/013
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: MHRA
   

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Page 1

Issued: 06 February 2007 at 15:00
Ref: MDA/2007/013

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd.

>Page 2

Problem:
The MHRA has received reports of:

  • inadequate ventilation in non-intubated patients
  • thoracic cage and lung damage
  • raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply.
  
Action by:
First responders, ambulance staff, A&E staff, cardiology staff and cardiothoracic surgical staff.		  

Action:

  • Ensure that all users of this device are aware of the ventilation update to the instructions for use from Jolife AB, appended to this Alert. This now states that when used in non-intubated patients the device can be safely stopped to allow intermittent manual ventilation.
  • Ensure the device is placed correctly, according to its instructions for use (IFU).
  • If the device is powered by oxygen and used in confined spaces (e.g. ambulances) ensure there is adequate ventilation. In ambulances always run the ventilation at the highest capacity and do not recirculate the air.
  • If the device is powered by oxygen always ensure there is an adequate oxygen supply for both the Lucas device and the patient’s respiratory requirements.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer/supplier contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3

Appendix:
Update to the manufacturer’s instructions for use (in pdf only).		  

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 28 February 2007
Deadline (action complete): 14 March 2007


Page last modified: 07 February 2008