BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 2.4GHZ

    MDR report key: 16543443 · Received March 15, 2023

    Report

    Report Number
    1218950-2023-00121
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 28, 2023
    Report Date
    December 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082243
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6 CONFIRMATION RECEIVED PATIENT DIED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT NO AUDIBLE ALARM AT THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. A PATIENTS DEATH WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT ARRESTED AND THERE WAS NO AUDIBLE ALARM AT THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. A PATIENTS DEATH WAS REPORTED. FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE OBTAINED THE REQUESTED PIIC LOGS AND MX40 PWM LOGS. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE LOGS. BASED ON THE REVIEW OF THE PIC IX AND MX40 PWM LOG AND ALARM REVIEW DATA, THE PSE DETERMINED THAT THE MX40 PERFORMED AS SPECIFIED AND RECOGNIZED AND ALARMED FOR CHANGES IN THE PATIENT¿S CONDITION. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT ARRESTED AND THERE WAS NO AUDIBLE ALARM. THE DEVICE WAS IN USE AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036331 INTELLIVUE MX40 2.4GHZ INTELLIVUE MX40 2.4GHZ MHX PHILIPS MEDICAL SYSTEMS MX40 - 2.4 00884838082243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L