BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CARDIOVASCULAR

    MDR report key: 25337029 · Received May 29, 2026

    Report

    Report Number
    3003768277-2026-101165
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 29, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE USER EXPERIENCED PROBLEMS IN RETRIEVING AND VIEWING OLD STUDIES IN INTELLISPACE CARDIOVASCULAR (ISCV). NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275840 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