inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received May 22, 2026 · Event occurred Apr 23, 2026

Report 3003768277-2026-101153 · MDR key 25254916

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • No Display/Image

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT CERTAIN IMAGES WERE NOT DISPLAYED IN ISCV (INTELLISPACE CARDIOVASCULAR). 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.