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MDA/2005/056 - GE Corometrics/Marquette 170 series fetal monitors, cardiotocographs

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/056
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/056
Issued: 25 October 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
GE Corometrics/Marquette 170 series fetal monitors, cardiotocographs.

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PROBLEM:
Electrical interference from the external power supply can be displayed as a valid fetal heart rate (FHR).

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ACTION BY:
Healthcare professionals working in maternity units, labour wards and antenatal clinics		  

ACTION:

  • Users should be aware that a ‘flat’ trace around 135 bpm or 181 bpm, may be due to interference and not the fetal heart rate.
  • Users should consider moving the external power supply away from the monitor, in accordance with the manufacturer’s recommendations in Annex 2.

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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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ANNEXES:
1. Sample noise waveform and photo of monitor and power supply
2. GE Medical Device Advisory Notice

 PDF



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Page last modified: 07 February 2008