inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jun 18, 2026 · Event occurred May 15, 2026

Report 3003768277-2026-101184 · MDR key 25552937

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Failure to Transmit Record

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT ISCV WAS IN ''WEB ONLY'' MODE AND THE USER WAS UNABLE TO EXPORT STUDIES. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.