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MHRA - Faulty defibrillator warning
Faulty defibrillator warning
People and organisations should check if they have the defibrillator models, LIFEPAK CR Plus and LIFEPAK EXPRESS Automatic External Defibrillators (AED), because an electrical fault with some of them may not deliver an electric shock to the heart to someone who is in cardiac arrest. Approximately 2,577 devices are defective.
These devices are available in public places such as schools, supermarkets, community centres and train stations. They are often known as public access defibrillators (PAD) as anyone can use them in an emergency.
The manufacturer, Physio-Control, has sent a safety alert to people with affected defibrillators, with instructions for action. Whilst 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.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical Device Alert.
The fault is due to an internal component (reed switch) that can intermittently become stuck in the closed position. This could fail to deliver a shock to resuscitate a patient.
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 5 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 5 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.
If they have not established a routine check process, they should refer to section 5 of the Operating Instructions for recommended actions.
If people have these defibrillators and not received the manufacturer’s safety alert, they should locate the serial number on the label on the back of the device and call the manufacturer’s customer support or visit their website to see if the device is affected.
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
Notes to Editor
- See the Medical Device Alert
- See the Field Safety Notlce
- See the manufacturers website 4.Physio-Control’s customer support details are: 0808 258 0094 from 9:00 – 17:00, Monday – Friday.
- Report any problems with medical devices via the Yellow Card Scheme
- MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health.www.mhra.gov.uk
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