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Isle of Man Government
Reiltys Ellan Vannin
Isle of Man Government Crest

O.F.T

Isle of Man Government Office of Fair Trading

Potentially Faulty Defibrillators

First aiders (for example in schools and sports facilities), are asked to check 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) in the UK 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 from August 2004 to December 2010.

What you need to do: Check the serial numbers to see if you have one of the affected defibrillators that needs its software updating. If you do have one of the affected defibrillators, contact the manufacturer’s helpline on 0845 604 8280 for advice on how to update the software. Alternatively, contact the MHRA Adverse Incident Centre on 020 7084 3080 or aic@mhra.gsi.gov.uk

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