HeartStart XL defibrillator/monitor - battery life and capacity test interval reduced

(Philips) Battery life reduced from 1.5 years to 1 year and capacity test interval reduced from 6 months to 3 months. (MDA/2013/066)

CAS deadlines

Action underway: 22 August 2013, action complete: 5 September 2013

Note: These deadlines are for the addendum to be attached to the instructions for use and service manuals.

Device

HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix.

Manufactured by Philips.

Distributed by Philips and Cardiac Services UK & Ireland.

HeartStart XL defibrillator-monitor

NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.

Problem

SeriousDefibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from 6 months to 3 months. This applies to new batteries with the lot number prefix ‘LK’.

Philips is supplying an addendum with battery orders and HeartStart XL monitor/defibrillator orders stating these changes (March 2013) to HeartStart XL instructions for use (edition 7) and HeartStart XL service manual (edition 6).

Action

Ensure all relevant staff are aware of the changes.

Ensure that the addendum (see appendix) is attached to the instructions for use and service manuals accordingly.

Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

Action by

All those responsible for the use or maintenance of the devices.

Distribution

This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS England area teams for information
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. 
Below is a suggested list of recipients.

Trusts
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 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
  • Clinical governance leads
  • Community defibrillation officers
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Dental departments
  • EBME departments
  • Equipment stores
  • Equipment libraries and stores
  • 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
  • Medical physics departments
  • Paramedics
  • Resuscitation officers and trainers
  • Risk managers
  • Theatre managers
  • Walk-in centres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Adult placement
  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Clinics
  • Hospices
  • 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.

Manufacturer contact

Customer Care Service Centre
Philips Healthcare
Philips Centre
Guildford
GU2 8XH

Tel: 0870 532 9741

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk.

Appendix

The addendum to be attached to the instructions for use and service manuals accordingly is included in the appendix at the end of the PDF.

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/066 or 2012/009/026/291/006.

Technical aspects

Ian Sealey or Yasser Zayni
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 6691 / 7238
Fax: 020 8754 3965

Email: ian.sealey@mhra.gsi.gov.uk or yasser.zayni@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7128
Fax: 020 8754 3965

Email: mark.grumbridge@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 CAS website

Northern Ireland

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

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website

Scotland

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

Incident Reporting and Investigation Centre
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

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

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

Download documents

Medical Device Alert: HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix manufactured by Philips (MDA/2013/066) (228Kb)

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