Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) have been completed.The reported problem (patient death) was confirmed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.Upon further investigation of the download data, the monitor had displayed service code 104, indicating a defective sd card.A defective sd card does not affect the monitor's ability to detect and treat an arrhythmia.Unavailability of retrospective ecg recordings did not cause or contribute to the this adverse event.The sd card is a data logger that only stores the patient's retrospective continuous ecg recordings.There is no real and active patient monitoring associated with the stored retrospective ecg recordings.The root cause of the defective sd card could not be positively identified.Device manufacturer date monitor: 07/29/2016, electrode belt: 12/18/2014.
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A us distributor contacted zoll to report that a patient had passed away on (b)(6) 2020.It was reported that the patient's passing was cardiac related and per the patient's nurse, the device was removed from the patient prior to passing.A review of the downloaded patient data flag files indicate that the patient received five unknown treatment events at 10:13:55, 10:14:31, 10:15:05, 10:16:32, and 10:24:00 on the date of death ((b)(6) 2020).The electrode belt was disconnected at 10:25:40 on (b)(6) 2020.The specific rhythm at the time of the treatment events is unknown.The downloaded data indicates that the device had displayed multiple service code 104 errors.There were no allegations of device malfunction contributing to the patient's death.The device was fully functional upon receipt.
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