INTELLISPACE CARDIOVASCULAR

Description of Event or Problem

PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLISPACE CARDIOVASCULAR) THAT PREVENTED THE USER FROM SAVING OR FINALIZING A STUDY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE COMPLAINT. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS CAUSED BY A DATABASE DISCREPANCY RELATED TO DIFFERENT REPORT VERSIONS. THIS DISCREPANCY RESULTED IN AN ERROR DURING THE SAVE PROCESS, WHICH PREVENTED THE REPORT FROM BEING SAVED. AS AN IMMEDIATE ACTION, A WORKAROUND WAS PROVIDED WHEREBY THE STUDY WAS COPIED TO LOCAL STORAGE, DELETED FROM ISCV, AND RESENT. FOLLOWING THIS THE USER WAS ABLE TO SUCCESSFULLY COMPLETE REPORTING ON THE STUDY. ALTHOUGH NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). THE MALFUNCTION HAS BEEN EVALUATED AND DEEMED REPORTABLE. UNDER CERTAIN CIRCUMSTANCES, THE ISSUE COULD POTENTIALLY RESULT IN A DELAYED DIAGNOSIS. GIVEN THE NATURE OF THE DEFECT AND ITS POTENTIAL IMPACT ON CLINICAL DECISION-MAKING IF IT WERE TO RECUR, PHILIPS HAS DETERMINED THAT THIS EVENT CONSTITUTES A REPORTABLE MALFUNCTION.