INTELLISPACE CARDIOVASCULAR
Received Jul 1, 2026 · Event occurred Mar 11, 2025
Report 3003768277-2026-101210 · MDR key 25675211
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 (INTELLISPACE CARDIOVASCULAR) SYSTEM WHEREIN SERVER STABILITY REPEATED INTERNAL 500 ERRORS ON WEB SERVER. 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.