Electrode belt sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files (attached) on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the inappropriate treatment.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.Monitor sn (b)(4) was returned to the distributor for evaluation.The evaluation of the monitor confirmed the service code 104/dl code 203.The sd card was defective.The distributor evaluation included downloaded data review as well as incoming functional testing of the device's ecg acquisition and pulse delivery circuitry, as recommended by zoll manufacturing.The monitor passed essential performance testing.The root cause of the defective sd card could not be positively identified.
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