There was no death or device malfunction associated with the inappropriate defibrillation events.Device evaluation summary: electrode belt (b)(4) and monitor (b)(4) were returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files (attached) 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 inappropriate treatment.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.Device manufacture date: monitor (b)(4): (b)(6) 2011 reuse.Electrode belt (b)(4): (b)(6) 2012 reuse.Additional inappropriate defibrillation narrative: the investigation into the event concludes that there was no device malfunction.A cause and effect analysis was conducted using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips.The primary cause of the inappropriate shock event was lack of response button use prior to shock delivery.The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was multiple counting of tall t-waves and motion artifact.The source of motion artifact cannot be positively identified through cause and effect analysis.The following factors could not be ruled out as contributing causes to the artifact: body motion improper garment laundering poor ecg contact with skin inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69% per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest.
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