Device evaluation of the monitor and electrode belt has been completed.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.There is no indication of a product malfunction.Device manufacture date: monitor 08/22/2016, belt 12/29/2015.
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A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2021.Review of the patient's download data indicates the patient received one inappropriate shock in response to oversensing of low amplitude cardiac signal and cpr/motion artifact on the date of passing.The device was started up at 18:18:59 on (b)(6) 2021.The patient was in severe bradycardia at 10 bpm with hb, unconducted p waves, and pvc's at 23:46:14 on (b)(6) 2021.The patient's rhythm degraded to asystole with cpr/motion artifact at 23:58:30.The patient received the inappropriate shock at 00:00:10 on (b)(6) 2021.The patient's rhythm at the time of the shock and post-shock rhythm were asystole with cpr/motion artifact.The patient was in asystole with cpr/motion artifact until the device shutdown at 00:43:59 on (b)(6) 2021.
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