MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received Jun 5, 2026 · Event occurred May 7, 2026
Report 3003768277-2026-101174 · MDR key 25406548
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
Description of Event or Problem
PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING THAT THE USER RECEIVED A WARNING MESSAGE "THE IMAGES FOR THIS STUDY ARE NOT ONLINE." WHEN ATTEMPTING TO OPEN ULTRASOUND EXAMINATIONS. 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.