BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 21872327 · Received April 21, 2025

    Report

    Report Number
    21872327
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS MX800 MONITOR IS CONFIGURED WITH OUR STANDARD NICU [NEONATAL INTENSIVE CARE] CONFIGURATION, WHICH INCLUDES RED ALARM FUNCTIONALITY THAT CALLS OUT INTO THE NURSE CALL SYSTEM, WHILE THE YELLOW AND CYAN ALARMS ARE CONFIGURED TO NOT CALL OUT. THIS MONITOR SUDDENLY CHANGED ITS CONFIGURATION FROM THIS FUNCTIONALITY INTO FULL ALARMING INTO THE NURSE CALL SYSTEM FROM ALL ALARMS: RED, YELLOW, AND CYAN. NURSE CALL CABLE AND PORT WERE INITIALLY REPLACED AND VERIFIED TO BE FUNCTIONING CORRECTLY. ISSUE WAS ISOLATED TO MX800. MX800 CONFIGURATION CAN ONLY CHANGE THROUGH SERVICE OR CONFIGURATION MODES AND SHOULD NOT BE ABLE TO REVERT TO ANOTHER CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259665 INTELLIVUE MX800 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown