BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 24416223 · Received February 23, 2026

    Report

    Report Number
    9610816-2026-100361
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 23, 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
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) CONTACTED THE CUSTOMER BIOMED. THE RSE WAS ADVISED THAT A GCX WALL RAIL MOUNT FAILED AND THE "SLED" BASE WAS DAMAGED CAUSING X3 TO BE DROPPED. THE BIOMED DID NOT KNOW HOW THE GCX WALL RAIL MOUNT HAD GOTTEN DAMAGED. THE BIOMED WAS REQUESTING PART IDENTIFICATION FOR THE "SLED" BASE CONNECTED TO RAIL MOUNT. THE RSE ADVISED THE CUSTOMER THAT FOR WALL MOUNTS, AND OTHER MOUNTING HARDWARE RELATED TO THE GCX WALL RAIL MOUNTS, THEY WOULD NEED TO CONTACT GCX MEDICAL MOUNTING SOLUTIONS AND PROVIDED THE CUSTOMER THE CONTACT PHONE NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GCX MOUNTING HARDWARE, WALL RAIL MOUNT FAILED AND THE "SLED" BASE WAS DAMAGED CAUSING X3 TO BE DROPPED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480647 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