INTELLISPACE CARDIOVASCULAR
Received Apr 23, 2026 · Event occurred Mar 24, 2026
Report 3003768277-2026-101073 · MDR key 24966550
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830084
Product problems
- Computer System Security Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER IS EXPERIENCING PERFORMANCE ISSUES AND A NETWORK THREAT WAS DETECTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT AND NO ADVERSE EVENTS OR HARM WERE REPORTED. THE COMPLAINT CONTAINED NO ALLEGATION OF SERIOUS INJURY OR DEATH. THE PROBLEM WAS UNABLE TO BE REPLICATED. CHECKS ON THE SERVER WERE PERFORMED AND NO ISSUE WAS FOUND. CUSTOMER CONFIRMED THAT SYSTEM IS PERFORMING NORMALLY. BASED ON THE RESULTS OF THE ANALYSIS, ISCV WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THIS RECORD IS CONSIDERED TO BE NON-REPORTABLE. NOTE: EVALUATION RESULTS AND CONCLUSION FDA C-CODE HAVE BEEN UPDATED.
Description of Event or Problem
IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER IS EXPERIENCING PERFORMANCE ISSUES AND A NETWORK THREAT WAS DETECTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT AND NO ADVERSE EVENTS OR HARM WERE REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.