The patient was inappropriately treated 1 time by the lifevest.The patient's neurological status at the time of the event is unknown.Multiple counting of the ecg signal contributed to the false detection.The response buttons were not pressed during the event.No injury was reported from the treatment.The patient was in the hospital prior to the event, during the event, and remained there following the event.The patient continued to use the lifevest.No deficiencies were alleged against the device.
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The monitor and electrode belt have not been returned for evaluation.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the inappropriate treatment.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, 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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