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MDA/2005/060 - Medtronic LIFEPAK® 12 defibrillator/monitor series: QUIK-COMBO™ cables and standard (hard) paddles

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/060
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/060
Issued: 04 November 2005

IMMEDIATE ACTION Tick mark
ACTION  
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Medtronic LIFEPAK®12 defibrillator/monitor series: QUIK-COMBO™ cables and standard (hard) paddles.		  
PROBLEM:
The pins in the connectors of cables and paddles can fatigue and break with potential for a loss of external pacing and defibrillation functions. Broken pins may remain in the female connector of the defibrillator preventing treatment and further use of the defibrillator.

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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:
All users:

  • Test, as a routine, all QUIK-COMBO™ cables and hard paddles using the 'therapy cable defibrillation check' described on page 8-7 and the 'standard paddles user test' described on page 8-3 of the instructions for use.
  • Continue to use cables and paddles that pass testing.
  • Quarantine the defibrillator and any cables or paddles which do not pass testing and contact the manufacturer for service immediately.

Where devices are used outside the hospital environment:

  • Identify QUICK-COMBO™ cables (part number xxxxxxx-006 or earlier) and standard (hard) paddles (part number xxxxxxx-013 or earlier). The manufacturer will contact all out-of-hospital users to arrange replacements free of charge.

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DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*

* via CE Bulletin

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

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> Further information supplied in the following pages.

Page last modified: 07 February 2008