INTELLISPACE CARDIOVASCULAR

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT SOME USERS CAN ONLY ACCESS INTELLISPACE CARDIOVASCULAR (ISCV) VIA THE WEB VERSION. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT (B)(4). THE COMPLAINT DID NOT INCLUDE ANY ALLEGATION OF SERIOUS INJURY OR DEATH. BASED ON THE INVESTIGATION CONDUCTED, THE REPORTED ISSUE COULD NOT BE REPRODUCED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED. GIVEN THAT THE RISK ASSESSMENT DETERMINED THAT, UNDER CERTAIN CIRCUMSTANCES, THE ISSUE COULD POTENTIALLY LEAD TO DELAYS IN CLINICAL WORKFLOW AND CONSIDERING THAT THE INVESTIGATION REMAINED INCONCLUSIVE DUE TO THE LACK OF CUSTOMER FEEDBACK, THE EVENT HAS BEEN CLASSIFIED AS REPORTABLE.