INTELLISPACE CARDIOVASCULAR
Received Apr 27, 2026 · Event occurred Apr 20, 2026
Report 3003768277-2026-101086 · MDR key 24997596
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 NOT ALL IMAGES WERE LOADING IN BOTH WEB VIEWER AND THICK CLIENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT. THE COMPLAINT CONTAINED NO ALLEGATION OF SERIOUS INJURY OR DEATH. BASED ON THE RESULTS OF THE ANALYSIS, ISCV (INTELLISPACE CARDIOVASCULAR) ARCHIVE INDICATED THAT THE AVAILABLE REPOSITORY CAPACITY WAS RUNNING LOW AND CONTRIBUTING TO THE IMAGE LOADING BEHAVIOR OBSERVED IN BOTH ISCV WEB VIEWER AND THICK CLIENT. AS AN IMMEDIATE ACTION, SERVICE PERSONNEL UNDERTOOK TARGETED REMEDIATION OF STALE STUDIES. CUSTOMER WAS ADVISED THEIR ACTIVE ARCHIVE IS FULL AND WAS REQUESTED TO NOTIFY THEIR IT (INFORMATION TECHNOLOGY) DEPARTMENT TO CREATE AN ADDITIONAL ACTIVE ARCHIVE. ISCV WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THIS RECORD IS CONSIDERED TO BE NON-REPORTABLE. NOTE: EVALUATION RESULTS AND CONCLUSION FDA C-CODE WERE UPDATED.
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT NOT ALL IMAGES WERE LOADING IN BOTH WEB VIEWER AND THICK CLIENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.