Zoll medical united kingdom evaluated the device and the device performed to specification.The customer's report was not observed during evaluation and functional testing of the device.The device was recertified and returned to the customer.Review of the data file showed the event has two of the three analysis segments under 100 microvolts (match for asystole).As two of the three analyses were not shockable, the device prompted "no shock advised".Per the zoll shock algorithm, 2 out of 3 segments have to be shockable in order to advise shock.The device worked as expected within the limitations of the technology.Analysis of reports of this type has not identified an increase in trend.
|