INTELLISPACE CARDIOVASCULAR
Received Jul 1, 2026 · Event occurred May 30, 2025
Report 3003768277-2026-101221 · MDR key 25676169
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLI SPACE CARDIOVASCULAR) SYSTEM WHEREIN THE COPY STUDY (WEB) IS NOT WORKING, IT IS SHOWING UNAUTHORIZED (401), NOT AUTHORIZED TO COMPLETE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. BASED ON THE NEW INFORMATION THAT PHILIPS BECAME AWARE, THIS HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION. 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, IT IS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION.