BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CARDIOVASCULAR

    MDR report key: 25109711 · Received May 7, 2026

    Report

    Report Number
    3003768277-2026-101115
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    September 5, 2025
    Report Date
    May 7, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LLZ
    UDI-DI
    00884838100107
    PMA / PMN Number
    K153022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344418 INTELLISPACE CARDIOVASCULAR CARDIOVASCULAR IMAGE AND INFORMATION MANAGEMENT SYSTEM LLZ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INTELLISPACE CARDIOVASCULAR 00884838100107

    Patients

    Seq Age Sex Outcome Treatment
    1