inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received May 27, 2026 · Event occurred May 7, 2026

Report 3003768277-2026-101155 · MDR key 25297437

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Application Program Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT ISCV (INTELLISPACE CARDIOVASCULAR) OPENS IN ''WEB ONLY'' MODE WITH REDUCED FUNCTIONALITY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.