BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 22464997 · Received July 9, 2025

    Report

    Report Number
    9610816-2025-000581
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    May 31, 2025
    Report Date
    August 1, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE LIMITED INFORMATION RECEIVED, IT CANNOT BE CONFIRMED WHETHER A DEVICE MALFUNCTION OCCURRED OR WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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

    THE FOLLOWING FUNCTIONAL/DIAGNOSTIC TESTING AND COMMUNICATIONS WERE PERFORMED; THE PHILIPS REMOTE CLINICAL APPLICATION SPECIALIST (CAS) SPOKE WITH THE BIOMED WHO CONFIRMED THAT THE X3 MONITOR IS CURRENTLY IN USE AND THE DEVICE IS PERFORMING AS EXPECTED. THE CAS REQUESTED AN ONSITE VISIT TO RETRIEVE THE CLINICAL AUDIT, TECHNICAL LOGS, AND CONFIRM THE MONITOR IS PERFORMING AS EXPECTED. A PHILIPS TECHNICAL CONSULTANT WENT TO THE CUSTOMER'S SITE AND PULLED LOGS. THE WORK ORDER INDICATES THE SYSTEM MEETS SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER CONTACT. ALTHOUGH DEVICE LOGS WERE AVAILABLE, NO DETAILS ABOUT THE PATIENT INCIDENT OR DEATH WERE PROVIDED AND NO DEVICE PROBLEM WAS ALLEGED; THEREFORE, THERE IS INSUFFICIENT INFORMATION FOR AN INVESTIGATION. BASED ON THE INFORMATION AVAILABLE THE CAUSE OF THE REPORTED PROBLEM WAS UNABLE TO BE DETERMINED. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED FOLLOWING A PATIENT INCIDENT, CLINICAL LEADERSHIP REQUESTED ASSISTANCE RETRIEVING AND REVIEWING THE CLINICAL AUDIT LOGS. THERE WAS A REQUEST FOR AN ON-SITE ENGINEER TO CONFIRM THE DEVICE WAS WORKING AS EXPECTED. IT WAS INDICATED THE PATIENT PASSED AWAY A FEW DAYS LATER BUT BIOMED WAS NOT SURE IF THE DEATH WAS RELATED TO THE INCIDENT. NO FURTHER DETAILS WERE PROVIDED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601790 INTELLIVUE MULTI-MEASUREMENT MODULE X3 INTELLIVUE MULTI-MEASUREMENT MODULE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death