BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 24317174 · Received February 11, 2026

    Report

    Report Number
    9610816-2026-100272
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 27, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT WAS DETERMINED SINCE THIS IS REFERRING TO PARAMETER MEASUREMENTS IN THIS CASE, THIS SHOULD BE RELATED TO THE INTELLIVUE X3. THE INTELLIVUE X3 PROVIDES INPUT SIGNALS FOR INVASIVE AND NON-INVASIVE MEASUREMENTS, WHICH CAN BE SYNCHRONIZED WITH OTHER MEDICAL DEVICES. THEREFORE, THE DEVICE INFORMATION WAS UPDATED. D1 BRAND NAME UPDATED FROM PHILIPS HEMO SYSTEM WITH INTELLIVUE X3 TO INTELLIVUE MULTI-MEASUREMENT MODULE X3. D2A PROCODE UPDATED FROM UNKNOWN TO MHX. D4 MODEL NUMBER UPDATED FROM PHILIPS HEMO SYSTEM WITH INTELLIVUE X3 TO INTELLIVUE X3 D4 CATALOG ITEM IDENTIFIER FROM 722467 TO 867030. D4 SERIAL NUMBER WAS UPDATED FROM (B)(6) TO NO INFORMATION. D4 UDI WAS UPDATED FROM (B)(4) TO NO INFORMATION. G4 510(K) UPDATED FROM UNKNOWN TO K171801. H4 DEVICE MANUFACTURE DATE UPDATED FROM 11/27/2024 TO NO INFORMATION.

    Additional Manufacturer Narrative · 0

    THE ECG PATIENT CABLE WAS REPLACED BY THE CUSTOMER WITH ONE FROM THEIR STOCK; THEREFORE, THE PART AND LOT NUMBER ARE UNKNOWN. PHOTOS OF THE REPLACED TRUNK CABLES WERE REQUESTED BUT NOT PROVIDED. ANALYSIS WAS PERFORMED BY ONSITE SERVICE PERSONNEL WHICH INCLUDED EFFORTS TO REPRODUCE THE REPORTED ISSUE. AS PART OF THE TROUBLESHOOTING PROCESS, CALIBRATION OF THE ARTERIAL PRESSURE CHANNELS (P1¿P4) WAS PERFORMED. FUNCTIONAL TESTING WAS CONDUCTED FOLLOWING THESE ACTIONS. THE SYSTEM MET THE MANUFACTURER¿S SPECIFICATIONS IN ALL TESTS PERFORMED AFTER CALIBRATION. THE DEVICE WAS CONFIRMED TO BE OPERATING AS INTENDED AND WAS DEEMED READY FOR CONTINUED CLINICAL USE. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS THE DEVICE AS OUT OF CALIBRATION. THE ISSUE WAS RESOLVED BY CALIBRATING THE ARTERIAL PRESSURE CHANNELS. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. IT WAS CONFIRMED THAT THE SYSTEM USED WAS THE HEMODYNAMIC SYSTEM WITH INTELLIVUE X3; THEREFORE, THE DEVICE INFORMATION WAS UDPATED. D1. BRAND NAME UPDATED FROM INTELLIVUE MULTI-MEASUREMENT MODULE X3 TO PHILIPS HEMO SYSTEM WITH INTELLIVUE X3, D2A. PROCODE UPDATED FROM MHX TO UNKNOWN, D4. MODEL NUMBER UPDATED FROM INTELLIVUE X3 TO PHILIPS HEMO SYSTEM WITH INTELLIVUE X3, D4. CATALOG ITEM IDENTIFIER FROM 867030 TO 722467, D4. SERIAL NUMBER WAS UPDATED FROM NO INFORMATION TO (B)(6), D4. UDI WAS UPDATED FROM NO INFORMATION TO (B)(4), G4. 510(K) UPDATED FROM K171801 TO UNKNOWN, H4. DEVICE MANUFACTURE DATE UPDATED FROM NO INFORMATION TO 11/27/2024.

    Additional Manufacturer Narrative · 0

    E1 REPORTING INSTITUTION PHONE #: (B)(6). A PHILIPS SENIOR FIELD SPECIALIST WENT TO THE CUSTOMER'S SITE. AS PART OF THE TROUBLESHOOTING PROCESS, CALIBRATION OF THE ARTERIAL PRESSURE CHANNELS (P1¿P4) WAS PERFORMED AND A NEW CATHETER WAS INSTALLED. FUNCTIONAL TESTING WAS CONDUCTED FOLLOWING THESE ACTIONS. THE SYSTEM MET THE MANUFACTURER¿S SPECIFICATIONS IN ALL TESTS PERFORMED AFTER CALIBRATION. THE DEVICE WAS CONFIRMED TO BE OPERATING AS INTENDED AND WAS DEEMED READY FOR CONTINUED CLINICAL USE. 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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE HEMODYNAMIC SYSTEMS WITH INTELLIVUE X3 INDICATING THAT THE PRESSURE FLUCTUATES MASSIVELY AT TIMES. THE BIOMED REPLACED THE TRUNK CABLES AND THE ERROR STILL OCCURS. THE BIOMED STATED AFTER RESTARTING IT WORKS AGAIN. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56893 INTELLIVUE MULTI-MEASUREMENT MODULE X3 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

    Patients

    Seq Age Sex Outcome Treatment
    1