INTELLISPACE CARDIOVASCULAR
Received Jul 1, 2026 · Event occurred Apr 30, 2025
Report 3003768277-2026-101212 · MDR key 25675210
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 INTERNALLY IN ISCV (INTELLISPACE CARDIOVASCULAR) WHEREIN THERE IS NOT A WAY TO HIGHLIGHT STAT PATIENTS. THE ISSUE WAS IDENTIFIED INTERNALLY AND WAS NOT 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.