MHRA issues warning over faulty defibrillators

The Medicines and Healthcare products Regulatory Agency (MHRA) has issues a warning directing people and organisations to check what they model of defibrillator they have, after the manufacturer reported an electrical fault.

The potentially faulty public access defibrillators (PAD) can be found in schools, supermarkets, community centres and train stations, and include: LIFEPAK CR Plus and LIFEPAK EXPRESS Automatic External Defibrillators (AED). The electrical fault means some of these models may not be able to deliver an electric shock to the heart to someone who is in cardiac arrest.

It is estimated around 2,577 devices are defective.

The manufacturer, Physio-Control, has sent a safety alert to people with affected defibrillators, with instructions for action. Although there have been no reported patient incidents, it is vital that the faulty defibrillators are identified and the manufacturer’s instructions are followed.

People have been directed to check that the serial number listed in their confirmation sheet matches the serial number on the label located on the back of the device.

To check if the PAD is faulty, the MHRA advises: “When the on/off button is pressed and the lid is opened a voice prompt may fail to initiate. If voice prompts are not activated within five seconds, people should remove their device, not use it and contact the manufacturer’s customer support to arrange for the reed switch to be replaced.

“If the voice prompt is initiated within five seconds, people with affected defibrillators can still use them but should continue to monitor them in line with their routine check process until contacted by the manufacturer, Physio-Control, to arrange for the reed switch to be replaced.”

John Wilkinson, MHRA’s director of Medical Devices said: “These devices deliver life-saving treatment and it is vital they operate correctly when needed in an emergency.

“Those who are responsible for them should carry out the checks recommended by the manufacturer. If the defibrillator is faulty, please remove it from use.

“If you have any questions, call Physio-Control on 0808 258 0094”