inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Apr 24, 2026 · Event occurred Mar 26, 2026

Report 3003768277-2026-101075 · MDR key 24977305

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

IT HAS BEEN REPORTED TO PHILIPS THAT THERE WAS ISSUE IN RETRIEVING THE OLDER STUDIES. MOST OF THE ECHOCARDIOGRAMS WERE NOT RETRIEVED DUE TO WHICH USERS COULD NOT ACCESS TO THE IMAGES. 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 OF THIS COMPLAINT.