Explanation: there was no death or device malfunction associated with the inappropriate defibrillation event.There is no indication that the patient sustained a serious injury.Device evaluation summary: monitor sn (b)(4) was returned to the distributor and the evaluation is currently underway.Electrode belt sn(b)(4) has not yet been recovered from the field.Device evaluation included review of downloaded software flag files on the day of the event.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.Approximately three hours prior to the treatment event, the patient's flags reveal instances of can comm timeout flags which lasted for about three seconds.The few instances of this flag does not indicate a device malfunction that would have contributed to the inappropriate treatment.Device manufacture date: monitor - 05/24/2016; belt - 06/20/2013.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 was improper response button use (response buttons were pressed earlier in the detection sequence but not immediately prior to treatment delivery).The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was motion artifact.The source of the motion artifact could not be positively identified through the cause and effect analysis.The following factors could not be ruled out as contributing causes of the motion artifact: 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 iec 60601-2-4 performance requirements for sensitivity and specificity.
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