There was no death or device malfunction associated with the inappropriate defibrillation.There is no info to suggest that the patient sustained a serious injury.Device evaluation was accomplished through a review of the patient's downloaded data file.Review of the data does not indicate any device malfunction related to the defibrillation event.Device mfg date(s): monitor (b)(4) - 01/2011, electrode belt (b)(4) - 06/2011.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).
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