BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CARDIOVASCULAR

    MDR report key: 23704485 · Received December 3, 2025

    Report

    Report Number
    3003768277-2025-015504
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 17, 2025
    Report Date
    April 7, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LLZ
    UDI-DI
    00884838122000
    PMA / PMN Number
    K153022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV SYSTEM WHERE THE CUSTOMER IS EXPERIENCING ERROR 500 WHEN OPENING AN ULTRASOUND STUDY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). ALTHOUGH NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT, THIS MALFUNCTION HAS BEEN DETERMINED TO BE REPORTABLE. UNDER SPECIFIC CIRCUMSTANCES, IT COULD POTENTIALLY LEAD TO DELAYED DIAGNOSIS OR MISDIAGNOSIS. 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. NOTE: THE EVALUATION METHOD FDA C-CODE HAS BEEN UPDATED IN THIS EMDR (7153733).

    Description of Event or Problem · 0

    PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV SYSTEM WHERE THE CUSTOMER IS EXPERIENCING ERROR 500 WHEN OPENING AN ULTRASOUND STUDY. NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). PHILIPS IS CURRENTLY UPDATING THE RISK MANAGEMENT MATRIX FOR THE ISCV PRODUCT. UNTIL THIS UPDATE IS COMPLETE, AND IN AN ABUNDANCE OF CAUTION, PHILIPS IS SUBMITTING A REGULATORY REPORT FOR ALL ISCV (INTELLISPACE CARDIOVASCULAR) PRODUCT MALFUNCTIONS ALLEGED IN COMPLAINT INVESTIGATIONS RELATING TO DATA AVAILABILITY UNTIL THE UPDATE OF THE RISK MANAGEMENT MATRIX IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849804 INTELLISPACE CARDIOVASCULAR CARDIOVASCULAR IMAGE AND INFORMATION MANAGEMENT SYSTEM LLZ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INTELLISPACE CARDIOVASCULAR 00884838122000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown