There was no death associated with the inappropriate defibrillation event.There is no indication that the patient sustained a serious injury following the event.Device evaluation summary: electrode belt sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.Monitor sn (b)(4) was returned to zoll manufacturing corporation for evaluation and the evaluation is currently underway.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing of the electrode belt.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 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 pulse delivery circuitry.The pulse delivery circuitry test verified proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.Device manufacture date: monitor: 04/08/2015.Belt: 04/13/2012.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 by the patient during the false detection, prior to shock delivery.The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was motion artifact.The source of the artifact could not be positively identified through cause and effect analysis.The following could not be ruled out as contributing factors: body motion.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.(b)(4).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.The lifevest detection algorithm complies with (b)(4) performance requirements for sensitivity and specificity.
|
A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event consisting of one shock.The patient was reportedly riding an atv at the time of the treatment event.The response buttons were not pressed during the event.Motion artifact contributed to the false detection.The patient was reportedly thrown off the atv after receiving the treatment, and as a result, suffered multiple broken ribs.Following the event, the patient was evaluated by medical personnel and continued wearing the lifevest.There was no death or device malfunction associated with the inappropriate defibrillation event.
|