Device evaluation of monitor sn (b)(4) has been completed. the reported problem (patient death) was confirmed. during the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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.Device evaluation of electrode belt sn (b)(4) has been completed.Upon investigation the electrode belt failed incoming testing.The cables connecting cables ecg "a" and ecg "b" and the front therapy electrode were pulled from the strain relief, damaging all wires and damaging the j704 and j703 connectors on the distribution node pca.The root cause for the strained cable was excessive force.Device manufacturer date: monitor: 02/22/2018, electrode belt: 11/17/2015.
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A us distributor contacted zoll to report that a patient had passed away on (b)(6) 2020 at approximately 2:08pm, while wearing the lifevest.The patient was in the er when they coded and an emergency team removed the device battery to perform cpr.It was reported that the patient was not conscious at the time of the event and that the device was alarming.The patient's passing was cardiac related.Per clinical review of the available ecg data, bradycardia status was detected at 12:09:25 on (b)(6) 2020.Asystole was detected two times from 12:13:01 to 12:13:34.Ecg shows idioventricular rhythm at 30 bpm degrading to asystole.The patient was in an idioventricular rhythm at 30 bpm degrading to asystole with cpr/motion artifact.The rhythm then degrades to ventricular fibrillation (vf) with cpr/motion artifact from approximately 12:13:11 until the device shutdown at 13:42:13 on (b)(6) 2020.The patient was in vf with cpr/motion artifact for approximately 21 seconds.Cpr/motion artifact prevented the lifevest from delivering a treatment from approximately 13:38:15 to 13:38:35.It was reported that medical professionals performed resuscitation efforts.There is no indication that a device malfunction caused or contributed to the patient's death.
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