LIFEPAK® 1000 defibrillator - risk of failure to deliver a shock

(Physio-Control) Due to unexpected shut down of the defibrillator caused by a battery with very low charge. (MDA/2014/040)

CAS deadlines

Action underway: 23 October 2014, action complete: 6 November 2014

Note: These deadlines are for operators to be aware of instructions and to check batteries.

Device

LIFEPAK 1000 defibrillator

LIFEPAK® 1000 defibrillator.
Manufactured by Physio-Control.
All serial numbers.

Problem

Risk of failure to deliver a shock.

This is due to unexpected shut down of the defibrillator caused by a battery with very low charge.

Confusing instructions for use mean that batteries aren’t always replaced when they have a low or very low charge.

See the Field Safety Notice (279Kb) for further details.

Action

  • Identify all LIFEPAK 1000 defibrillators in your possession.
  • Ensure users read the important information in the Field Safety Notice and follow the instructions on how to check if a new battery is required.
  • Make sure that a spare, fully charged battery is always available.

Action by

All staff responsible for the use, maintenance and purchase of these 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 co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams for information
  • NHS trusts in England (chief executives)
  • Special health authorities for information

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
  • Ambulance services directors
  • Ambulance staff
  • Biomedical engineering staff
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Clinical governance leads
  • EBME departments
  • Health and safety managers
  • Intensive care units
  • Intensive care, directors of
  • Maintenance staff
  • Medical directors
  • Medical physics departments
  • Nursing executive directors
  • Resuscitation officers and trainers
  • Risk managers

Independent distribution

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

  • 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

Olivier Anki
Physio-Control Operations Netherlands B.V.
Galjoenweg 68, 6222 NV
Maastricht
The Netherlands

Tel:    +33 695 475 522

Email:    olivier.anki@physio-control.com

Feedback

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

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/040 or 2014/007/010/081/006

Technical aspects

Paul Sandhu or Yasser Zayni
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel:    020 3080 7266 / 7238
Fax:  020 8754 3965

Email: paul.sandhu@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

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other 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

Incident Reporting and Investigation Centre 

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel:    029 2082 5801

Email:    Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: LIFEPAK® 1000 defibrillator manufactured by Physio-Control (MDA/2014/040) (100Kb)

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