INTELLISPACE CARDIOVASCULAR

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING THAT THE USER WAS UNABLE TO LOG IN WITH AN ERROR (HTTP ERROR 503) DISPLAYED. 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 INTERNET INFORMATION SERVICES (IIS) AND RE-STARTING THE APPLICATION POOL 'CARDIOPACSPOOL'. IN ADDITION, THE PHILIPS SERVICE ENGINEER EXECUTED A SCRIPT TO MONITOR THE ISCV APPLICATION POOLS, ALLOWING THE ¿CARDIOPACSPOOL¿ APPLICATION POOL TO BE AUTOMATICALLY RESTARTED IF 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.