Zoll medical canada evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.The device's ecg data was returned to zoll medical corporation; evaluation of the data indicated the device was powered up in manual mode then 4 seconds into the case the device was switched to pace mode.Per zoll medical's specifications, the device will not acquire ecg signal in pace mode under the pad leads, only ecg leads.The device was powered off after multiple cable changes and clearing of pads off messages.The device reset to defib mode, cleared pads off message, and the ecg signal was acquired.Therefore the device met specification.It is noteworthy to mention the ecg leads and electrode pads used at the time of the reported event were not returned for evaluation.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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