INTELLISPACE CARDIOVASCULAR
Received Apr 27, 2026 · Event occurred Apr 1, 2026
Report 3003768277-2026-101084 · MDR key 24995456
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT HAS BEEN REPORTED TO PHILIPS THAT IMAGES ARE NOT LOADING WHEN PULLED FROM PACS LINK FOR A CERTAIN STUDY. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. BASED ON THE RESULTS OF THE ANALYSIS, THERE IS A REPOSITORY FOLDER REGISTERED IN THE DATABASE BUT THE FOLDER IS MISSING FROM THE DRIVE, AND THE STUDY HAS NOT BEEN ARCHIVED. THE ROOT CAUSE IS UNKNOWN AND COULD NOT BE IDENTIFIED. NOTE: EVALUATION RESULTS AND CONCLUSION FDA C-CODE WERE UPDATED.
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT IMAGES ARE NOT LOADING WHEN PULLED FROM PACS LINK FOR A CERTAIN STUDY. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.