inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jun 26, 2026 · Event occurred May 28, 2026

Report 3003768277-2026-101201 · MDR key 25634656

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Unintended Application Program Shut Down

Patient

NA · 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 THICK CLIENT WAS CRASHING INTERMITTENTLY. 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.