INTELLISPACE CARDIOVASCULAR

Additional Manufacturer Narrative

IT HAS BEEN REPORTED TO PHILIPS THAT CUSTOMER EXPERIENCED REPEATED CRASHES OF IIS (INTERNET INFORMATION SERVICES) ON APPLICATION SERVER. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THE COMPLAINT CONTAINED NO ALLEGATION OF SERIOUS INJURY OR DEATH. BASED ON THE RESULTS OF THE ANALYSIS, WINDOWS EVENT VIEWER LOGS DISPLAY ERRORS IN WHICH THE 'CARDIOPACSPOOL' IS BEING DISABLED DUE TO A SERIES OF FAILURES IN THE PROCESS SERVING THAT APPLICATION POOL. NO REASON FOR THE OUTAGES COULD BE DETERMINED. HOWEVER, BASED ON THE TYPE OF ERRORS FOUND, THE MOST PROBABLE CAUSE IS THE ANTI-VIRUS SCANNER NOT SUPPORTING THE REQUIRED EXCEPTION CONFIGURATION. AS AN IMMEDIATE ACTION, SERVICE PERSONNEL REMOVED 19,000 UNCLEARED IIS TEMP FILES AND INCREASED THE TOLERANCE THRESHOLD AT WHICH THE 'CARDIOPACSPOOL' IS DISABLED. THE CUSTOMER REPORTED SIGNIFICANT IMPROVEMENT AFTERWARD. CUSTOMER WAS ALSO ADVISED TO CHANGE THE ANTIVIRUS AND CONFIGURE EXCEPTIONS. BASED ON THE AVAILABLE INFORMATION, THIS RECORD IS CONSIDERED TO BE NON-REPORTABLE. NOTE: EVALUATION RESULTS AND CONCLUSION FDA C-CODE UPDATED.

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT CUSTOMER EXPERIENCED REPEATED CRASHES OF IIS (INTERNET INFORMATION SERVICES) ON APPLICATION SERVER. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.