BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE PATIENT MONITOR MX700

    MDR report key: 25067970 · Received May 4, 2026

    Report

    Report Number
    9610816-2026-100847
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 4, 2026
    Report Date
    May 27, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. D4 UNIQUE DEVICE IDENTIFIER (UDI): THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO (B)(6) 2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE HEART RATE CORRECTED INTERVAL (QTC) MEASUREMENTS ARE CONSISTENTLY HIGH. 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
    23573 INTELLIVUE PATIENT MONITOR MX700 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown