Medical Device Alert: PediCap carbon dioxide detector manufactured by Covidien (MDA/2010/026)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/026 or 2009/008/025/081/024.

Technical aspects
Mr J Lefever or Dr C Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3262/3219
Fax: 020 7084 3209

Email: jim.lefever@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mr J Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

A modification to the indicator paper in the detector may result in:

• increased resistance to airflow
• inadequate sensing of carbon dioxide (CO2), as the indicator does not change colour
• delay in detection of an incorrectly placed breathing tube.

• Identify and quarantine affected devices, as listed in the manufacturer’s Field Safety Notice.
• Contact Covidien to arrange return of, and receive credit for, the affected devices.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• NHS boards and trusts in Wales (chief executives)
• Primary care trusts in England (chief executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E departments
• All wards
• Ambulance staff
• Anaesthetic nursing staff
• Anaesthetists
• Day surgery units
• EBME departments
• Equipment stores
• High dependency units
• Intensive care units
• Maternity units
• Medical physics departments
• Midwifery departments
• Operating department practitioners
• Paediatric intensive care units
• Paediatric outpatients
• Paediatric wards
• Paramedics
• Resuscitation officers and trainers
• Risk managers
• Special care baby units
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Independent treatment centres

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Resuscitation officers

Mr B Cole Covidien

Tel: 07710 597 649
Fax: 0203 027 1758

Email: ben.cole@covidien.com