A us distributor contacted zoll to report that a patient passed away while wearing the lifevest.Review of the patient's download data revealed that prior to passing, the patient received 3 inappropriate treatments from the lifevest.At 12:12:10, the patient received the first treatment.The patient's rhythm at the time of the treatment was severe bradycardia at 10 bpm with cpr and motion artifact.The post-shock rhythm was asystole.At 12:14:14, the patient received the second treatment.The patient's rhythm at the time of the treatment was asystole, and the post-shock rhythm was also asystole.At 12:14:47, the patient received the third treatment.The patient's rhythm at the time of the treatment was asystole, and the post-shock rhythm was also asystole.The patient remained in asystole until the electrode belt was disconnected at 12:15:59.There's no indication that a device malfunction caused or contributed to the patient's passing.
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Device evaluation of the monitor and electrode belt 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.
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