inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jun 6, 2026 · Event occurred May 5, 2026

Report 3003768277-2026-101171 · MDR key 25419497

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Loss of Data

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER EXPERIENCED AN UNEXPECTED ISCV SERVER FAILURE, WHICH RESULTED IN THE LOSS OF CLINICAL PATIENT DATA. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.