BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX450 PATIENT MONITOR

    MDR report key: 19860322 · Received July 30, 2024

    Report

    Report Number
    19860322
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    November 25, 2023
    Report Date
    July 11, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MONITOR SCREEN WENT OUT DURING CT SCAN. PATIENT WAS NOT MONITORED FOR MINUTES UNTIL ANOTHER STAFF MEMBER BROUGHT IN A NEW MONITOR FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200725 INTELLIVUE MX450 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX450

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male