Model Number WCD 4000 |
Device Problems
Signal Artifact/Noise (1036); Decreased Sensitivity (2534); High Sensing Threshold (2574)
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Patient Problems
Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130)
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Event Date 11/06/2021 |
Event Type
Death
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Manufacturer Narrative
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Device evaluation of the monitor has been completed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download ((b)(6) 2021) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.No deficiencies alleged.Device manufacture date: monitor: 02/24/2021, belt: 06/02/2014.
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Event Description
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A us distributor contacted zoll to report that a patient passed away in the hospital while wearing the lifevest on (b)(6) 2021.Review of the patient's download data indicates the patient received one appropriate shock and three external defibrillations on the date of passing.The device was started up at 19:40:53 on (b)(6) 2021.The patient was in an idioventricular rhythm at 40 bpm, transitioning to svt at 150 bpm with cpr/motion artifact at 03:15:20 on (b)(6) 2021.The patient's rhythm degraded to vf with cpr/motion artifact at 03:18:14.The patient received the appropriate shock at 03:18:51.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was vt at 250 bpm, self-converting to sinus bradycardia at 45 bpm with cpr/motion artifact and electrode lead fall off.The patient was in sinus bradycardia/sinus tachycardia from 30 to 140 bpm with hb and cpr/motion artifact.The patient received the first external defibrillation at 03:30:28.The patient's rhythm at the time of the shock was sinus rhythm at 80 bpm with cpr/motion artifact and electrode lead fall off.The patient's post-shock rhythm was sinus rhythm at 90 bpm.The patient received the second external defibrillation at 03:33:43.The patient's rhythm at the time of the shock and post-shock rhythm were sinus rhythm at 80 bpm with cpr/motion artifact and electrode lead fall off.The patient's rhythm degraded to vt from 150 to 160 bpm at approximately 03:36:40.The patient's rhythm then degraded to vf with cpr/motion artifact and electrode lead fall off.The patient received the third external defibrillation at 03:37:06.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was sinus tachycardia at 120 bpm with cpr/motion artifact and electrode lead fall off.Cpr/motion artifact, electrode lead fall off, and the external defibrillation prevented the lifevest from detecting the vt/vf arrhythmia.The patient was in sinus tachycardia/sinus rhythm from 120 to 60 bpm with pvc's, cpr/motion artifact and electrode lead fall off.The patient's rhythm then degraded to vt from 120 to 150 bpm with cpr/motion artifact and electrode lead fall off at 03:52:49.The patient remained in vt until the electrode belt disconnection at 03:53:49 on (b)(6) 2021.Cpr/motion artifact, electrode lead fall off, the rate of the vt arrhythmia varying below the physician-prescribed rate threshold of 150 bpm, and the electrode belt disconnection prevented the lifevest from detecting the vt arrhythmia.
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Search Alerts/Recalls
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