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Cardiotocograph

Notice type: Advisory

Date: 14/02/2003

  

Product name or type:
Cardiotocograph

Reference:
SN2003(02)

Manufacturer Or Supplier:
Various

Target Audience:
Consultant Obstetricians; Directors of Midwifery; Medical and Midwifery Staff; Community Midwives; Clinical Risk Managers; Clinical Engineering Staff

Problem Or Issue:
Fluid Ingress through the maternal display of the foetal monitor.

Background Information Or Related Documents:
The IMB have received an adverse incident report indicating a short circuit between the two channels of the foetal monitor. This would appear to be a rare event and the risk of death or injury is negligible as stated by the manufacturer. Should such an incident occur the equipment cross channel verification system at set up would have operated and alerted the operator to the problem.   

On examination the manufacturer found that the probable cause of the short circuit was corrosion in the channel unit. The channel unit was replaced and the device operated correctly.

Cardiotocograph Document

Actions To Be Taken:

The IMB advise that users of this product:   

  • Ensure that all staff dealing with this device is made aware of the possible risk of fluid ingress.  
  • Ensure that the manufacturers guidelines relating to Spillage and Care and Cleaning are followed.  
  • Ensure that the device is maintained and serviced as outlined by the manufacturer.
  • Report any indications of problems to the device to the Irish Medicines Board

Further Information:
All adverse incidents relating to a Medical Device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2  

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:        +353 1 6764971 
Fax:                  +353 1 6767836 
Email:               vigilance@imb.ie
Website:            www.hpra.ie

SN2003(02): Cardiotocograph

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