Defibrillators May Fail - Says Medical Devices Regulator

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 25 Nov 2008 - 1:00 PST

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First aiders and users of Medtronic Physio-Control LIFEPAK CR Plus automatic external defibrillators (AED) are being told today to test their device by the Medicines and Healthcare products Regulatory Agency (MHRA) following advice from the manufacturer over concerns that the defibrillator could fail to turn on and work due to a faulty internal cable.

These defibrillators are supplied for use in offices, schools, sports facilities and hotels to provide potentially life saving first aid treatment to cardiac arrest victims prior to the arrival of the emergency services.

LIFEPAK CR Plus automatic external defibrillators manufactured between November 2006 and March 2008 need to be checked by following the manufacturer's instructions.

- Immediately verify your AED powers on and voice prompts begin.
- Perform monthly inspections that include the additional AED power on test. A monthly inspection is consistent with the LIFEPAK CR Plus operating instructions.
- If "OK" is visible on the Readiness Display and the AED powers on, it is ready for use.
- If the AED does not power on ,or the readiness display indicates a malfunction, then immediately call the manufacturer on 01923 234 512

Clive Bray, Director of Device Technology and Safety at the MHRA said, "We are requesting that people be extra vigilant and test their defibrillators as soon as possible, as a faulty device could result in the failure to give life-saving treatment."

"People can report any safety related issues concerning medical devices to the MHRA by calling our Adverse Incident Hotline on 020 7084 3080 or via the website at http://www.mhra.gov.uk."

A Medical Device Alert (MDA) has been issued today to all those involved in the provision, use and maintenance of LIFEPAK CR Plus automatic external defibrillators manufactured by Medtronic Physio-Control. These include medical, nursing and paramedical staff, resuscitation training officers, community defibrillation officers and technical staff responsible for the use, maintenance and purchase of these devices.

Notes

1. If you are unsure about your particular Medtronic Physio control LIFEPAK CR Plus automatic external defibrillators (AED) then you can contact the UK supplier on 01923 234 512. The affected serial numbers can be found on the MHRA website. The contact details for the UK supplier are:

David Dunham or Michael Brunton
Medtronic Limited
Suite One Building
5 Croxley Green
Business Park
Watford
WD18 8WW
Tel: 01923 234 512
Fax: 01923 241 004
E-mail: david.dunham@medtronic.com
Michael.brunton@medtronic.com

2. There are 430 affected devices that have been supplied to the UK. The MHRA has received no adverse incident reports regarding this issue.

3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone -the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

MHRA