A us distributor contacted zoll to report that a patient passed away on (b)(6) 2023 while reportedly wearing the lifevest.The patient received five inappropriate treatments.The device was started up at 18:08:53 on 1/22/2024.At 10:21:48 on (b)(6) 2024, an arrhythmia was detected.Ecg shows asystole with motion/tactile artifact.At 10:22:27, the patient received the first inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with motion/tactile artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with motion/tactile artifact.At 10:30:00, the patient received the second inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with motion/tactile artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with motion/tactile artifact.At 10:30:37, the patient received the third inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with motion/tactile artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with motion/tactile artifact.At 10:31:04, the patient received the fourth inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with motion/tactile artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with motion/tactile artifact.At 10:31:47, the patient received the fifth inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with motion/tactile artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with motion/tactile artifact.The electrode belt was disconnected at 11:10:51 on 1/23/2023.
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Device evaluation of the monitor has been completed.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 product malfunction.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.
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