IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected.

Manufactured by Philips Healthcare: Error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ECG trace, distorting the ST segment, leading to risk of misinterpretation or misdiagnosis. (MDA/2017/031)

Action

  • Identify affected devices, which are listed in the Field Safety Notice.
  • Ensure that users understand and follow the instructions in the Field Safety Notice, in particular, the advice for correctly responding to ‘ECG Check Cable’ or ‘ECG Noisy Elec xx’ error messages.
  • Ensure a Philips Healthcare representative arranges to install the software upgrade as soon as it becomes available.
  • Contact Philips Healthcare to acknowledge receipt of the Field Safety Notice as soon as possible.

Action by

Medical, nursing and technical staff involved in the use and maintenance of these devices

Deadlines for actions

Actions underway: 5 October 2017

Actions complete: 26 October 2017

Note that these deadlines are for users to be made aware of the issue, not for completion of the software upgrade.

Manufacturer contacts

Manufacturer contacts
Philips Customer Care Service Centre
Tel: 0870 532 9741

claudia.romagnuolo@philips.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and NICAS 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 departments
  • All staff
  • All wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Biomedical engineering staff
  • Biomedical science departments
  • Cardiac laboratory technicians
  • Cardiac pacing technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Colposcopy departments
  • Community defibrillation officers
  • Community hospitals
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • District nurses
  • EBME departments
  • Endocrinology units
  • Endocrinology, directors of
  • ENT departments
  • ENT medical staff
  • ENT services, directors of
  • Equipment stores
  • Equipment libraries and stores
  • Gastroenterology departments
  • Gastroenterology, directors of
  • Gastro-intestinal surgeons
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Haematologists
  • Haemodialysis nurses
  • Haemodialysis units
  • Health and safety managers
  • In house maintenance staff
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • Maintenance staff
  • Minor injury units
  • Maternity units
  • Maxillofacial departments
  • Medical directors
  • Medical physics departments
  • Midwifery departments
  • Midwifery staff
  • MRI units, directors of
  • Neonatal nurse specialists
  • Neonatology departments
  • Neonatology directors
  • NHS walk-in centres
  • Nursing executive directors
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics departments
  • Obstetrics nurses
  • Operating department practitioners
  • Ophthalmology departments
  • Oral surgeons
  • Orthopaedic surgeons
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric medicine, directors of
  • Paediatric nurse specialists
  • Paediatric oncologists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Paediatric wards
  • Paediatricians
  • Paediatrics departments
  • Paramedics
  • Patient transport managers
  • Peritoneal dialysis units
  • Radiation & medical oncology departments
  • Radiology departments
  • Renal medicine departments
  • Resuscitation officers and trainers
  • Risk managers
  • Special care baby units
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Urological surgeons
  • Urology departments
  • Walk-in centres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/031 or 2017/008/024/291/025.

Technical aspects

Phillip Davenport / Andrew Marsden, MHRA

Tel: 020 3080 6461/ 7205

phillip.davenport@mhra.gov.uk / andrew.marsden@mhra.gov.uk

Clinical aspects

Kate Antrobus, MHRA Devices Clinical Team

Tel: 020 3080 7274

kate.antrobus@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

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

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Fax: 0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

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

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2017/031 - IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected

Published 28 September 2017