Potentially Faulty Defibrillators – Safety Notice

First aiders in shopping centres, railway stations, dental surgeries and other public places are asked to identify if they have a specific defibrillator that could potentially give incorrect advice to anyone using it to give CPR to someone having heart problems.

The defibrillator – called the Samaritan® PAD 500P defibrillator made by Heartsine Technologies Ltd – has a software fault that may incorrectly advise the user to ‘push slower’ during CPR when, in fact, the CPR rate is at an acceptable level.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert about this issue following a global correction notice issued by the manufacturer that provides advice about how first aiders and anyone responsible for these defibrillators can update the software.

The serial numbers for defibrillators affected are from 10B0010001 to 14B00461703 and they were sold in the UK from August 2004 to December 2010.

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

It’s vital that first aiders or anyone who is responsible for a defibrillator used in public places such as shopping centres, railway stations and dental surgeries check the serial numbers to see if they have one of the affected defibrillators that needs its software updating.

If they do, people can contact the manufacturer’s helpline on 0845 604 8280 who can provide advice about how to update the software or the MHRA Adverse Incident Centre on 020 7084 3080 or aic@mhra.gsi.gov.uk.

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