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Warning over faulty defibrillators that may not shock

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Organisations should check whether they have faulty versions of the automatic external defibrillator models LIFEPAK CR Plus and LIFEPAK EXPRESS, according to a safety alert.

An electrical fault with some devices means they may not deliver an electric shock when needed, said the Medicines and Healthcare products Regulatory Agency. Around 2,577 devices are defective.

“It is vital that these devices work in an emergency”

John Wilkinson

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

While there have been no reported patient incidents, it is important that the manufacturer’s instructions are followed by completing and returning the confirmation sheet immediately, it added.

The fault is due to an internal component – a reed switch – that can intermittently become stuck in the closed position and could, therefore, fail to deliver a shock to resuscitate a patient.

Medicines and Healthcare products Regulatory Agency

Warning over faulty defibrillators that may not shock

LIFEPAK CR Plus

The MHRA said 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.

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 to arrange for the reed switch to be replaced.

If they have not established a routine check process, they should refer to section five of the operating instructions for recommended actions, said the MHRA’s medical device alert.

Medicines and Healthcare products Regulatory Agency

Warning over faulty defibrillators that may not shock

LIFEPAK EXPRESS

Anyone with the affected type of defibrillator who has not received the manufacturer’s safety alert is advised to locate the serial number on the label on the back of the device and call the manufacturer’s customer support or visit its website.

John Wilkinson, MHRA’s director of medical devices, said: “These devices deliver life-saving treatment and it is vital that they work in an emergency.

“Those responsible for them should carry out the instructions by the manufacturer,” he said.

He added: “If you have any questions, or have not got the manufacturer’s safety alert, call Physio-Control’s customer support on 0808 258 0094.”

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