MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received Apr 27, 2026 · Event occurred Mar 31, 2026
Report 3003768277-2026-101093 · MDR key 25003075
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Missing Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT IMAGE FROM A STUDY WAS MISSING IN INTELLISPACE CARDIOVASCULAR (ISCV). NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.