The device was returned to zoll medical canada for evaluation and the device performed to specification.The device was put through extensive testing without duplicating a fault.The device was recertified and returned to the customer.The analysis algorithm incorporated in zoll defibrillators works by taking multiple three-second ecg segments.The algorithm then makes calculations based on ten waveform characteristics for each segment.In general, a minimum of two of the three segments need to be identified as "shockable" to have a result of shock advised.The main contributing waveform characteristics for this decision were higher qrs variability measurements, a higher recorded amplitude variability, and higher recorded qrs rates.The device worked as designed and within the limitations of the technology.Analysis of reports of this type has not identified an increase in trend.
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