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Medical device alert issued over defibrillator model LIFEPAK 1000 AED (22 May 2017)

Date: 22/05/2017
Duncan Lewis, Legal News Solicitors, Medical device alert issued over defibrillator model LIFEPAK 1000 AED

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking organisations to check public access defibrillators for a technical fault.

Those who have the defibrillator model LIFEPAK 1000 Automatic External Defibrillators (AED) should check it is working, after the discovery of a technical fault with some of the machines means they may not deliver an electric shock to the heart to someone who is in cardiac arrest.

The fault is due to intermittent connection between the battery and device contacts because of wear and subsequent corrosion between both components – this could fail to deliver a shock to resuscitate a patient.

It is also important that the manufacturer’s instructions are followed, by completing and returning the confirmation sheet immediately. MHRA says that people should check that the serial number listed in their confirmation sheet matches the serial number on the label located on the back of the device.

As part of the maintenance and testing schedule, users of the LIFEPAK 1000 Defibrillator should always follow the Operating Instructions, which direct users to routinely inspect both the battery well and battery contacts – especially if devices have been exposed to vibrations, or the battery has been installed for an extended period without being removed.

If a device powers off unexpectedly – either during inspection or during patient treatment – the user should immediately remove and reinstall the existing battery to restore power to the device. If power is not restored, the battery should be replaced with a spare battery and Physio-Control should be called immediately to arrange for servicing of the unit.

MHRA also advises that it is important to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices, until contacted by Physio-Control to arrange repair for any affected devices.

Removing and reinstalling the battery on a weekly basis will help make sure the device is ready for use – it is also important to always carry a fully charged spare battery.

This issue could potentially affect all LIFEPAK 1000 devices – there are 10,068 devices in the UK, which are available in public places, such as schools, airports, football stadiums and leisure centres. They are also found in hospitals, clinics and ambulances.

They are often known as public access defibrillators (PAD) as they are intended for use by anyone – the manufacturer’s logo on the front cover may vary, displaying Medtronic or Physio-Control.

The manufacturer, Physio-Control, has sent a safety alert to people with affected defibrillators, with instructions for action.

Anyone who has not received an FSN from the manufacturer should contact them directly. The Medicines and Healthcare products Regulatory Agency has also issued a Medical Device Alert.

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

“These devices deliver life-saving treatment – and it is vital they operate correctly when needed in an emergency.

“People who are responsible for them should carry out the checks recommended by the manufacturer.

“If you have any questions, please contact Physio-Control on 0808 258 0094.”


Duncan Lewis Clinical Negligence Solicitors

Duncan Lewis Clinical Negligence Solicitors can advise NHS patients who have suffered injury as a result of cardiac care negligence on how to make a no win no fee claim for compensation, including claims involving:

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  • Cardiac negligence claims have to be made within three years of the date when it became evident that negligence had occurred – children can make clinical negligence claims for cardiac care up to the age of 21.

    For expert legal advice on no win no fee Cardiac Negligence Claims, call Duncan Lewis clinical negligence solicitors on 0333 772 0409.

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