BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 22077143 · Received May 23, 2025

    Report

    Report Number
    9610816-2025-000418
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    December 12, 2024
    Report Date
    May 23, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A SUPPLEMENTAL TO 1051786-2025-000001 DUE TO INCORRECT REGISTRATION NUMBER USED. E1: REPORTING INSTITUTION PHONE # (B)(6). E1: REPORTER PHONE # (B)(6). D4: UDI IS NOT AVAILABLE DUE TO UNKNOWN SERIAL NUMBER. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: A FIELD SERVICE ENGINEER WENT ONSITE TO EVALUATE THE DEVICE AND FOUND IT TO BE WORKING AS EXPECTED. NO TROUBLE WAS FOUND. FURTHER RELEVENAT INFORMATION WAS REQUESTED (LIKE IF WAVES AND PARAMETER VALUES WERE NOT UPDATING (STATIC) OR WERE PRESENTING PRIOR/STALE DATA), BUT NONE WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, PHILIPS WAS NOT ABLE TO REPLICATE THE REPORTED PROBLEM AND THE EXACT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS DURING TESTING. HOWEVER, THE EXACT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE WAVEFORMS INTERMITTENTLY HANGS ON THE PHILIPS HEMO SYSTEM WITH INTELLIVUE X3, ZEROING IS NOT POSSIBLE. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261835 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown