We have received the follow message below via national ACRE to raise awareness in village halls of the potential problem with some defibrillators.
We are contacting you because we have been informed that there is an electrical fault with some LIFEPAK CR Plus and LIFEPAK EXPRESS Automatic External Defibrillators (AED). This means that some of them may not deliver an electric shock to the heart to someone who is in cardiac arrest. 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.
We are asking you to contact your network to inform them of this issue and to explain that it is vital that they follow the manufacturer’s instructions by completing and returning the confirmation sheet immediately. The manufacturer, Physio-Control, has already sent a safety alert to people with the LIFEPAK CR Plus AEDs and LIFEPAK EXPRESS AEDs with instructions for action. 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 to see if their defibrillator is affected.
Customers may also visit the Physio-Control website and enter the serial number here http://www.physio-control.com/ProductNotices.aspx. The full Field Safety Notice is also available here https://mhra.filecamp.com/public/file/2fqs-ct9k6m5d and the Medical Device Alert is available here https://www.gov.uk/drug-device-alerts/automatic-external-defibrillator-aed-lifepak-cr-plus-and-lifepak-express-risk-of-failure-to-deliver-a-shock .
Whilst there have been no reported patient incidents, it is important that the manufacturer’s instructions are followed. If people have questions regarding their AEDs, please call Physio-Control customer support on 0808 258 0094. If you have any further questions please do contact me on 020 3080 6640 or on email@example.com
Engagement Specialist Medicines and Healthcare Products Regulatory Agency 151 Buckingham Palace Road, London, SW1W 9SZ Telephone: 020 3080 6640 Email: firstname.lastname@example.org Web: mhra.gov.uk Stay connected: mhra.gov.uk/stayconnected