XLTEK BRAIN MONITOR

Description of Event or Problem

PATIENT WAS BEING MONITORED ON EEG FOR POTENTIAL SEIZURE ACTIVITY. THE ALARM FROM THE EEG SYSTEM DID NOT ALERT AS EXPECTED BY CLINICIANS. INVESTIGATIVE FINDINGS INDICATED THAT THE SOFTWARE THAT ELICITS THE ALARM WENT INTO A PAUSE STATE TEMPORARILY. THE SOFTWARE HAS SINCE BEEN UPDATED AND ACCORDING TO PERSYST THE PATCH SHOULD PREVENT A RE-OCCURRENCE. MANUFACTURER RESPONSE FOR EEG ACQUISITION MODULE, NA (PER SITE REPORTER): THE MANUFACTURER OF THE SOFTWARE PERSYST ANALYZED ERROR LOGS AND FINDINGS INDICATED A PROBLEM THAT THEY COULD NOT REPLICATE IN THEIR ENVIRONMENT. HOWEVER, THEY HAVE PROVIDED A PATCH TO ADDRESS THE PROBLEM