Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was confirmed.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.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a monitor malfunction.Electrode belt sn (b)(4) has not been returned for evaluation.Device evaluation includes review of downloaded software flag files on the days surrounding the event.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 patient treatment/death.Device manufacture date: monitor: 07/25/2017, belt: 11/07/2015.
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