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.
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A us distributor contacted zoll to report that a patient passed away on (b)(6) 2024 while reportedly wearing the lifevest.The patient received an inappropriate treatment.The device was started up at 19:03:08 on (b)(6) 2024.At 04:50:54 on (b)(6) 2024, an arrhythmia was detected.Ecg shows asystole with cpr/motion artifact.At 04:51:39, the patient received the inappropriate treatment.Oversensing of low amplitude cardiac signal and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.Rhythm at the time of treatment was asystole.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with cpr/motion artifact.The electrode belt was disconnected at 05:28:00 on (b)(6) 2024.
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