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MDA/2005/058 - Spacelabs 5 lead ECG cable: part number 012-012301 Batch numbers 31942, 34956, 35209, 35296, 35747, 36239 and 36555.

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/058
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/058
Issued: 26 October 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  

 

  Further Information
DEVICE:
Spacelabs 5 lead ECG cable: part number 012-012301
Batch numbers 31942, 34956, 35209, 35296, 35747, 36239 and 36555.		  
PROBLEM:
The yellow (left arm) and green (left leg) leads of some batches of their 5 lead ECG cable, part number 012-0123-01, have been cross connected.

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ACTION BY:
All nursing, medical and technical personnel using these devices.		  

ACTION:

  • Identify leads with the affected batch numbers
  • If faulty leads are identified contact Spacelabs Medical UK for replacements
  • When replacements are available, affected leads should be destroyed

 >

DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*

* via CE Bulletin

 >

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

 >



> Further information supplied in the following pages.

Page last modified: 07 February 2008