MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received May 29, 2026 · Event occurred May 1, 2026
Report 3003768277-2026-101164 · MDR key 25327030
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Patient Data Problem
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 THAT, WITH THE ISCV EPIC XML INTEGRATION, THE MEASUREMENTS IN ISCV DO NOT MATCH WITH THOSE IN EPIC AND MAY OVERWRITE THEM WHEN ISCV IS RE-OPENED. 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.