Device evaluation summary: monitor sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the event.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the device, 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 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.Electrode belt sn (b)(4) was returned for zmc for evaluation.Upon receipt the electrode belt was unable to undergo functional testing due to a biohazard.A visual inspection did not indicate any apparent damage to the electrode belt.The device evaluation included review of downloaded software flag files on the day of the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the event.
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A us distributor reported to zoll that a patient was treated prior to passing away.The patient received an appropriate full energy (150j) treatment shock on (b)(6) 2017.The patient was in vf at the time of the treatment.The shock failed to convert the arrhythmia and the post-shock rhythm remained vf.The patient transitioned to asystole, a non-shockable rhythm and no additional lifevest treatments were delivered.Asystole and cpr artifact were visible on the lifevest prior to device shutdown around 12:28:28 on (b)(6) 2017.The patient was found while unconscious and paramedics were called to the scene.It was reported that paramedics were able to restore a pulse; however, the patient had no neurological activity at that time.The patient was transported to the icu and was on a ventilator before passing away on (b)(6) 2017.
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