inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jul 17, 2026 · Event occurred Jun 19, 2026

Report 3003768277-2026-101257 · MDR key 25852391

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Application Program Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING THAT THERE WAS ERROR 500 REPORTED BY THE USERS IN ISCV. 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 FOR THIS COMPLAINT.