INTELLISPACE CARDIOVASCULAR
Received May 7, 2026 · Event occurred Sep 5, 2025
Report 3003768277-2026-101115 · MDR key 25109711
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Failure to Transmit Record
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLISPACE CARDIOVASCULAR) WHEREIN THERE IS A FAILURE TO SENT ECG (ELECTROCARDIOGRAM), (FOUND IN THE EXPORT_STAGE FOLDER OF THE SERVER). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. ALTHOUGH NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4), THIS MALFUNCTION HAS BEEN DETERMINED TO BE REPORTABLE. UNDER SPECIFIC CIRCUMSTANCES, IT COULD POTENTIALLY LEAD TO DELAYED DIAGNOSIS. GIVEN THE DEFECT¿S NATURE AND ITS POTENTIAL IMPACT ON CLINICAL DECISION-MAKING IF IT WERE TO RECUR, PHILIPS HAS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION.