BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 24560487 · Received March 10, 2026

    Report

    Report Number
    9610816-2026-100478
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838000261
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER WHO INDICATING THAT THE DOWN POST ON THE GCX ARM BROKE OFF AND THE X2 FELL OFF AND HIT THE FLOOR. ON FURTHER INVESTIGATION THE RSE WAS ADVISED THAT THE DOWN POST ON THE ARM HAD BECOME LOOSE OVER THE YEARS AND WAS BEING HELD ON BY ONLY A ONE OR TWO SCREWS. THE SCREWS SHEARED OFF AND THE X2 FELL. IT WAS UNKNOWN WHO ORIGINALLY INSTALLED THE GCX ARM. 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 A MAINTENANCE ISSUE. THE CUSTOMER REMOUNTED THE GCX ARM TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GCX ARM BROKE OFF AND THE X2 FELL OFF AND HIT THE FLOOR. 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
    621346 INTELLIVUE MULTI MEASUREMENT SERVER X2 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 865039 00884838000261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown