BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 25225437 · Received May 19, 2026

    Report

    Report Number
    9610816-2026-100983
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 20, 2026
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A SUPPLEMENTAL TO MFR 1051786-2026-100011 AS THE REPORT WAS REPORTED UNDER THE INCORRECT PRODUCT AND CFN FEI NUMBER. PLEASE REFER TO THIS COMPLETE REPORT RELATED TO THE PRODUCT INTELIVUVE X3. E1; REPORTER INSTITUTION PHONE NUMBER: (B)(6). E1: REPORTER PHONE NUMBER: (B)(6). ANALYSIS WAS PERFORMED BY THE FIELD SERVICE ENGINEER (FSE) AND CONFIRMED THE CUSTOMER ALARM TONE WAS ON MUTE. THE LOUDNESS FOR THE ECG WAS SET TO ALMOST 0 FOR THIS PARTICULAR PROCEDURE CARD. CUSTOMER WASN¿T AWARE ON HOW TO CHANGE AND SAVE THE LOUDNESS SETTINGS. PROCEDURE CARDS ADAPTED AND STORED ACCORDING TO THE CUSTOMER'S WISHES. BASED ON THE RESULTS OF THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS DUE TO THE VOLUME TURNED LOW. THIS WAS MOST LIKELY AN UNINTENDED ISSUE. THE FSE ADAPTED AND STORED THE PROCEDURE CARDS TO THE CUSTOMER'S WISHES. WHERE THE LOUDNESS IS SET TO A HIGHER VOLUME AND SAVED THIS VALUE FOR THEIR STANDARD PROCEDURE CARD. SHOWED THE CUSTOMER ON HOW TO CHANGE OR CREATE PROCEDURE CARDS. THIS RESOLVED THE CUSTOMER ISSUE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE X3 PATIENT MONITOR INDICATING THAT THE HEMO ALARM TONE TOO QUIET. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377312 INTELLIVUE MULTI-MEASUREMENT MODULE X3 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown