MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received May 13, 2026 · Event occurred Mar 27, 2026
Report 3003768277-2026-101124 · MDR key 25158513
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Data Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO PHILIPS THAT MULTIPLE STUDIES HAD NOT YET BEEN ARCHIVED. AS PART OF FURTHER ANALYSIS, ADDITIONAL INFORMATION INDICATED THAT THERE WERE MISSING FOLDERS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. THE INVESTIGATION IS ONGOING FOR THIS COMPLAINT.