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Press release: First aiders warned of potentially faulty defibrillators

Press release

Date: 20 November 2012
Time: 14:00
Subject: First aiders warned of potentially faulty defibrillators.
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

First aiders in shopping centres, railways, dental surgeries and other public places are today being asked to identify defibrillators made by HeartSine Technologies Ltd. This is due to two potential faults with some defibrillators that could lead to depleted batteries and hence the device being unavailable for use in the event of a person having a sudden cardiac arrest in a public place.

Some samaritan® PAD 300/300P defibrillators are faulty because they may either turn on or off when not in use, which could drain the battery power. In addition, defibrillators with early versions of the battery management software may misinterpret a low battery voltage which could turn the defibrillator off.

The manufacturer, HeartSine Technologies Ltd, has issued a global correction notice for samaritan® PAD 300/300P defibrillators distributed from August 2004 to December 2010. Serial numbers for devices affected by these issues are below:

0400000501 to 0700032917 inclusive
08A00035000 to 10A00070753 inclusive
10C00200000 to 10C00210318 inclusive

No other HeartSine samaritan®PAD 300/300P defibrillators are affected by the issues that are the subject of this press release.

HeartSine Technologies Ltd has distributed 1387 samaritan® PAD 300/300P devices with the serial numbers listed above in the UK. HeartSine are issuing affected customers with a reserve battery so that emergency care can be given to patients in the event of a low battery and instructions on how the software can be upgraded.

John Wilkinson, the MHRA’s Director of Medical Devices, said:

“People who are responsible for these public access defibrillators that are in use at shopping centres, railway stations, dental surgeries and other public places need to check the serial numbers and, if they have an affected device, follow the advice in the manufacturer’s field safety notice.

“If the defibrillator is part of this corrective action, and you are unsure of what to do, you can contact the manufacturer HeartSine on +44 02 8 9093 9400 or the MHRA Adverse Incident Centre on 020 3080 7080 or aic@mhra.gsi.gov.uk

Notes to Editor

1. Please see link below to Medical Device Alert:
Medical Device Alert: Samaritan public access defibrillator manufactured by HeartSine (MDA/2012/079)

2. Please see link below to HeartSine Technologies Ltd’s field safety notice:
Reserve battery and new instructions for users of the PAD 300/PAD 300P (Public Access Defibrillator)

3. Adverse incidents relating to medical devices can be reported to the MHRA website www.mhra.gov.uk. Information and printed incident report forms are available from: the MHRA Adverse Incident Centre on 020 7084 3080 or email: aic@mhra.gsi.gov.uk

4. 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.
Page last modified: 26 November 2012