inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jun 12, 2026 · Event occurred May 15, 2026

Report 3003768277-2026-101187 · MDR key 25485058

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Failure to Transmit Record

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 THE USER WAS UNABLE TO EXPORT IMAGE. 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.