INTELLISPACE CARDIOVASCULAR

Additional Manufacturer Narrative

PHILIPS IDENTIFIED A SOFTWARE DEFECT IN THE INTELLISPACE CARDIOVASCULAR (ISCV) WHEREIN THE CUSTOMER ENCOUNTERED A SERVICE UNAVAILABILITY ISSUE, WITH AN ERROR (HTTP ERROR) DISPLAYED IN THE ISCV. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED, AND THE CAUSE OF THE REPORTED PROBLEM WAS THE INTERNET INFORMATION SERVICES (IIS) CRASH, WHICH RESULTED IN THE APPLICATION POOL 'CARDIOPACSPOOL' WAS COMPLETELY STOPPED. AS AN IMMEDIATE ACTION, THE ISSUE WAS RESOLVED BY RESETTING THE IIS. IN ADDITION, THE PHILIPS SERVICE ENGINEER IMPLEMENTED A SCHEDULED TASK TO AUTOMATICALLY RESTART THE APPLICATION POOL 'CARDIOPACSPOOL' IN THE EVENT THAT THE SERVICE STOPS. ALTHOUGH NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT, THIS MALFUNCTION HAS BEEN DETERMINED TO BE REPORTABLE. UNDER SPECIFIC CIRCUMSTANCES, IT COULD POTENTIALLY LEAD TO DELAYED DIAGNOSIS. GIVEN THE DEFECT¿S NATURE AND ITS POTENTIAL IMPACT ON CLINICAL DECISION-MAKING IF IT WERE TO RECUR, PHILIPS HAS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION. NOTE: THE EVALUATION RESULTS FDA C-CODE, AND CONCLUSION FDA C-CODE HAVE BEEN UPDATED IN THIS EMDR.

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT THE CUSTOMER ENCOUNTERED A SERVICE UNAVAILABILITY ISSUE, WITH AN ERROR (HTTP ERROR) DISPLAYED IN THE INTELLISPACE CARDIOVASCULAR (ISCV). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.