BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 22197669 · Received June 12, 2025

    Report

    Report Number
    9610816-2025-000478
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 17, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED 510K FROM K150310 TO K171801. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER, AND THEY IDENTIFIED THE SPEAKER MALFUNCTION ERROR MESSAGE ON THE X3 DEVICE. THE FSE ADVISED THE CUSTOMER TO USE ONE OF THE BACKUPS X3 TEMPORARILY UNTIL THE ONSITE INSPECTION. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: ONCE ONSITE THE FSE TESTED THE DEVICE AND COULD NOT REPLICATE THE ISSUE. THE WERE NO ISSUES WITH THE DEVICE AND IT WAS OPERATING TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS NOT CONFIRMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE FSE FOUND THE DEVICE TO BE WORKING TO SPECIFICATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Additional Manufacturer Narrative · 0

    E1: REPORTER PHONE NUMBER: (B)(6). 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

    IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTION ERROR MESSAGE. IT IS UNKNOWN IF THE DEVICE PRODUCED SOUND AT TIME OF REPORT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973006 INTELLIVUE MULTI-MEASUREMENT MODULE X3 INTELLIVUE X3 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown