inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jul 16, 2026 · Event occurred Jun 16, 2026

Report 3003768277-2026-101256 · MDR key 25839557

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

PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING THAT THE IMAGES WERE AVAILABLE IN THE PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), BUT AN ERROR OCCURRED WHEN ATTEMPTING A QUERY/RETRIEVE (Q/R) FROM ISCV. 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.