BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 24754716 · Received April 1, 2026

    Report

    Report Number
    9610816-2026-100623
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 21, 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
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION THIS CASE WAS DETERMINED TO BE A DUPLICATE REPORT. ALL INFORMATION REGARDING THIS REPORTED ALLEGATION CAN BE FOUND IN MFR REPORT NUMBER 9610816-2026-100704.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NON-INVASIVE BLOOD PRESSURE (NIBP) VALUES WERE OUTSIDE THE SPECIFIED VALUE RANGE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NON-INVASIVE BLOOD PRESSURE (NIBP) VALUES WERE OUTSIDE THE SPECIFIED VALUE RANGE. IT IS UNKNOWN IF THE DEVICE WAS 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
    599082 INTELLIVUE MULTI MEASUREMENT SERVER X2 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2 00884838000261

    Patients

    Seq Age Sex Outcome Treatment
    1