MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received May 28, 2026 · Event occurred Apr 30, 2026
Report 3003768277-2026-101160 · MDR key 25312527
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Application Program Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS IDENTIFIED A SOFTWARE DEFECT INTERNALLY IN THE INTELLISPACE CARDIOVASCULAR (ISCV) THAT WHEN CHANGING PATIENT LINKING CONFIGURATIONS IN SECTION "STEP 2" OF THE SYSTEM ADMINISTRATION MANAGER, A CHECKBOX IN SECTION "STEP 1" WAS RESET. THE ISSUE WAS IDENTIFIED INTERNALLY AND WAS NOT IN CLINICAL USE AT THE TIME OF EVENT. PHILIPS INVESTIGATION IS ON-GOING.