inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received May 12, 2026 · Event occurred Apr 27, 2026

Report 3003768277-2026-101125 · MDR key 25147278

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 STUDY COMMENTS EXCEEDING 64 CHARACTERS DID NOT APPEAR IN THE "STUDY COMMENT" FIELD IN ISCV (INTELLISPACE CARDIOVASCULAR). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.