Medical Device Alert: Welch Allyn CP200 Electrocardiograph (MDA/2010/056)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/056 or 2010/004/020/291/002.

Technical aspects
Geoff Smith or Catriona Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3198 / 3219
Fax: 020 7084 3209

Email: geoff.smith@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and 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

When using the CP 200 in Auto ECG and Stat ECG modes, it is possible to print a previous patient’s ECG (without patient identifier) if the Auto ECG Post-Print screen is not exited properly in accordance with the manufacturer’s instructions.

Consequently, there is a risk of patients receiving the wrong ECG report leading to misdiagnosis and incorrect treatment.

The CP 200 has an Auto ECG mode where the user can override the required patient identifier. Moreover, the Stat ECG mode generates an ECG report without an associated patient identifier. The ECG report will then not display patient identification.

If the user does not exit the Auto ECG Post-Print screen after printing a Stat ECG for a patient, before connection to a new patient, and presses the “print copy” soft key instead of the Auto ECG button, a duplicate of the previous patient’s ECG report with no identifiers will be printed. The user may then believe the print copy belongs to the new patient.

Welch Allyn have distributed a Field Safety Notice re-enforcing the appropriate Directions for Use, together with a software upgrade to limit printing of ECG reports, without associated patient identifiers, to a single copy. This problem does not occur when using the Normal Auto ECG mode as it requires the patient identification to be entered before printing an ECG report.

• Identify all CP200 models.
• Users are recommended to contact Welch Allyn Technical Support for a copy of the upgraded software and install as soon as possible; unless established clinical workflow dictates otherwise.
• Users should observe the important safety information contained in the Field Safety Notice, including the recommendations to always:-
• • Write the patient identification information on the printed report.
  • Exit the Auto ECG Post-Print screen by pressing the exit button after printing.
  • Press the Auto ECG button to obtain an ECG report for the next patient.

Ensure users are aware that only a single copy of the ECG Report can be printed once the upgraded software has been installed. The Print Copy feature will not be available if no Patient Name or ID is entered.

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 consultants
• A&E departments
• A&E directors
• A&E nurses
• Adult intensive care units
• All clinical departments
• All staff
• All wards
• Biomedical engineering staff
• Cardiac care units
• Cardiac laboratory technicians
• Cardiac physiologists
• Cardiologists
• Cardiology departments
• Cardiology nurses
• Cardiology, directors of
• Clinical governance leads
• EBME departments
• Equipment stores
• Health and safety managers
• Medical directors
• Medical physics departments
• Nursing executive directors
• Outpatient clinics
• Outpatient theatre managers
• Outpatient theatre nurses
• Paediatric intensive care units
• Risk managers
• Special care baby units

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

• Care homes providing nursing care (adults)
• Clinics
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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

• Community hospitals
• Equipment libraries and stores
• General practitioners
• Minor injury units
• NHS walk-in centres
• Practice managers
• Practice nurses
• Walk-in centres

Ms Jennifer Judge
Regulatory Affairs Team Lead International Vigilance
Welch Allyn Limited
Navan Business Park
Navan
County Meath
Ireland

Tel: 020 7365 6780
Fax: +353 46 906 7755

Email: fieldsafetynotice@welchallyn.com