Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problems
Over-Sensing (1438); Structural Problem (2506)
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Patient Problem
Arrhythmia (1721)
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Event Date 02/22/2024 |
Event Type
malfunction
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Event Description
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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 05:05:20 on (b)(6) 2024.At 19:38:16, an arrhythmia was detected.Ecg shows asystole.At 19:38:51, the patient received the inappropriate treatment.Oversensing of low amplitude cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole.Post shock rhythm was bradycardia @ 40 bpm degrading to asystole with pvc¿s.The device was shut down at 06:44:38 on (b)(6) 2024.
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Manufacturer Narrative
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Device evaluation of the monitor 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.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download 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.
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Manufacturer Narrative
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Device evaluation of electrode belt has been completed.The reported problem (did not pass incoming testing) has been confirmed.Upon investigation the cable connecting ecg "a" and ecg "b" was severed, damaging wires in the cable.The root cause for the strained cable was excessive force.There is no indication the severed cable caused or contributed to the patient death as the latest available ecg recording strip indicates both ecg electrodes were functional as they were able to acquire a signal.Device evaluation of the monitor 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.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download 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.
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Event Description
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The electrode belt was returned for investigation and did not pass incoming functional testing.A us distributor contacted zoll to report that a patient passed away on 2/22/2024 while reportedly wearing the lifevest.The patient received an inappropriate treatment.The device was started up at 05:05:20 on 2/21/2024.At 19:38:16, an arrhythmia was detected.Ecg shows asystole.At 19:38:51, the patient received the inappropriate treatment.Oversensing of low amplitude cardiac activity contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole.Post shock rhythm was bradycardia @ 40 bpm degrading to asystole with pvc¿s.The device was shut down at 06:44:38 on 2/22/2024.
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Search Alerts/Recalls
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