MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received May 11, 2026 · Event occurred Apr 13, 2026
Report 3003768277-2026-101123 · MDR key 25134576
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Failure to Transmit Record
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING EPIC (A 3RD PARTY HOSPITAL INFORMATION SYSTEM OR RADIOLOGY INFORMATION SYSTEM) INTEGRATION ISSUES RELATED TO DCMIMPORTD, RESULTING IN STUDIES AND MEASUREMENTS WERE NOT CROSSING TO EPIC. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT (B)(4). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.