BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX40 1.4GHZ

    MDR report key: 23358798 · Received October 22, 2025

    Report

    Report Number
    1218950-2025-000618
    Event Type
    Death
    Date Received
    October 22, 2025
    Date of Event
    September 20, 2025
    Report Date
    November 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL ENGINEER (RCE) INTERVIEWED THE CUSTOMER WHO INDICATED THEY WERE ASKED BY CLINICAL LEADERSHIP TO BE INVOLVED IN A ROOT CAUSE ANALYSIS FOR ALARM ACTIVITY LEADING UP TO THE PATIENT EVENT AT A TIME BETWEEN (B)(6). THE RCE ASSISTED THE CUSTOMER WITH THE ALARM CAPABILITIES OF THE UNIT'S ALARMS. THE RCE ALSO DISCUSSED THE USE OF CLINICAL AUDIT TRAIL, BUT THE CUSTOMER WAS WORKING REMOTELY AND DID NOT HAVE ACCESS TO THE CENTRAL STATION. THE RCE ATTEMPTED TO LOG INTO THE PRIMARY VIA PHILIPS REMOTE SERVICES (PRS). UNFORTUNATELY, THE RCE COULD NOT LOG INTO SYSTEM CONFIGURATION TO CHECK CLINICAL AUDIT TRAIL DUE TO PASSWORD CHANGES AFTER A RECENT SYSTEM UPGRADE. A PHILIPS TECHNICAL CONSULTANT (TC) WAS CONTACTED TO ASSIST WITH THE CUSTOMER'S REQUEST FOR CLINICAL INFORMATION. THE TC CONFIRMED THE CUSTOMER'S REQUEST FOR CLINICAL ALARM REPORTING AND REMOTED INTO ONE OF THE CENTRAL STATION PCS. THE TC VERIFIED THE STEPS AND THE APPROPRIATE FILTERING TO GENERATE THE CLINICAL ALARM REPORT THAT THE CUSTOMER WANTED. THE REQUIRED DATA WAS ULTIMATELY SECURED AND PRESERVED WITHIN THE RETENTION WINDOW. PLANS WERE MADE FOR AN ONSITE MEETING; HOWEVER, THE CUSTOMER LATER PAUSED FURTHER ACTION PENDING INTERNAL DISCUSSIONS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL ENGINEER (RCE) INTERVIEWED THE CUSTOMER WHO INDICATED THEY WERE ASKED BY CLINICAL LEADERSHIP TO BE INVOLVED IN A ROOT CAUSE ANALYSIS FOR ALARM ACTIVITY LEADING UP TO THE PATIENT EVENT AT A TIME BETWEEN 9/19 2200-9/20 0300 IN 6 PALMETTO RM 6415. THE RCE ASSISTED THE CUSTOMER WITH THE ALARM CAPABILITIES OF THE UNIT'S ALARMS. THE RCE ALSO DISCUSSED THE USE OF CLINICAL AUDIT TRAIL, BUT THE CUSTOMER WAS WORKING REMOTELY AND DID NOT HAVE ACCESS TO THE CENTRAL STATION. THE RCE ATTEMPTED TO LOG INTO THE PRIMARY VIA PHILIPS REMOTE SERVICES (PRS). UNFORTUNATELY, THE RCE COULD NOT LOG INTO SYSTEM CONFIGURATION TO CHECK CLINICAL AUDIT TRAIL DUE TO PASSWORD CHANGES AFTER A RECENT SYSTEM UPGRADE. A PHILIPS TECHNICAL CONSULTANT (TC) WAS CONTACTED TO ASSIST WITH THE CUSTOMER'S REQUEST FOR CLINICAL INFORMATION. THE TC CONFIRMED THE CUSTOMER'S REQUEST FOR CLINICAL ALARM REPORTING AND REMOTED INTO ONE OF THE CENTRAL STATION PCS. THE TC VERIFIED THE STEPS AND THE APPROPRIATE FILTERING TO GENERATE THE CLINICAL ALARM REPORT THAT THE CUSTOMER WANTED. THE REQUIRED DATA WAS ULTIMATELY SECURED AND PRESERVED WITHIN THE RETENTION WINDOW. PLANS WERE MADE FOR AN ONSITE MEETING; HOWEVER, THE CUSTOMER LATER PAUSED FURTHER ACTION PENDING INTERNAL DISCUSSIONS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL SITE CONFIRMED THERE WERE NO ALLEGATIONS OF HARM OR DEVICE MALFUNCTION, AND THAT THE DEVICE WAS NOT A FACTOR IN THE DEATH OF THE PATIENT. THE TEAM REQUESTED ACCESS TO MX40 ALARM DATA AS PART OF AN ANALYSIS FOR A PATIENT EVENT. IT WAS NOTED THAT THE CUSTOMER HAS WHAT THEY NEED, AND NO ADDITIONAL SUPPORT IS WARRANTED. SUMMARY OF TECHNICAL COMPLAINT INVESTIGATION: THE LOGS WERE DOWNLOADED BY THE PHILIPS TC AND SENT TO THE INTERNAL PRODUCT SUPPORT ENGINEER FOR FURTHER ANALYSIS. THE PSE RESPONDED TO THE TC'S SUBMISSION INDICATING THE INFORMATION DID NOT CONSIST OF AUDIT LOGS, OR LOGS FROM THE SURVEILLANCE CENTER THAT WAS MONITORING THE PATIENT AND THAT THIS INFORMATION FROM THE PHYSIO SERVERS CANNOT BE USED TO ADDRESS THIS CUSTOMER¿S REQUEST. BASED ON THE INFORMATION AVAILABLE AND LOGS PROVIDED, THE CAUSE OF THE REPORTED PROBLEM WAS NOT CONFIRMED DUE TO INSUFFICIENT INFORMATION/LOGS PROVIDED BY THE CUSTOMER. THE REPORTED PROBLEM WAS NOT CONFIRMED. ALTHOUGH, THERE WAS INSUFFICIENT INFORMATION SUPPLIED BY THE CUSTOMER, IT WAS CONFIRMED BY THE BIOMEDICAL ENGINEER THERE WERE NO ALLEGATIONS OF HARM OR DEVICE MALFUNCTION, AND THAT THE DEVICE WAS NOT A FACTOR IN THE DEATH OF THE PATIENT. IT HAS BEEN REPORTED THAT THE CUSTOMER HAS THE INFORMATION THEY REQUESTED, AND NO ADDITIONAL SUPPORT WAS WARRANTED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE REVIEWING ALARMS THAT OCCURRED LEADING UP TO THE PATIENT DEATH. BIOMED INDICATED THERE WAS NO DEVICE MALFUNCTION AND THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403823 INTELLIVUE MX40 1.4GHZ MX40 1.4 GHZ SMART HOPPING MHX PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D