BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE PATIENT MONITOR MX700

    MDR report key: 25148493 · Received May 12, 2026

    Report

    Report Number
    9610816-2026-100914
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 12, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838029088
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE CLINICAL SUPPORT (RCS) CONTACTED THE CUSTOMER BIOMED WHO STATED THE MONITOR SHOWED THE PATIENT'S ELECTROCARDIOGRAM (ECG) HEART RATE VALUE = 125 BEATS PER MINUTE (BPM) BUT THE MONITOR DID NOT GENERATE A HEART RATE (HR) YELLOW OR RED VISUAL OR AUDIBLE ALARM. THE RCS ADVISED THE BIOMED TO CHECK THE MONITORS' ECG DEFAULT ALARM SETTINGS. THE BIOMED CONFIRMED THE FOLLOWING SETTINGS: MONITORS HEART RATE (DEFAULT) LIMITS = LOW 45- HIGH 150 BPM - EXTREME ALARMS +/- 20. THE RCS THEN ADVISED THE BIOMED TO CHECK THE PATIENT'S ECG- HR TABULAR TRENDS (UNDER PIC IX TREND REVIEW). THE BIOMED PROVIDED THE FOLLOWING RESULT: TREND REVIEW SHOW THE HEART RATE VALUE =125 BPM AT ON (B)(6) 2026 4:27AM - PATIENT'S ECG STRIP SHOWS HEART RATE VALUE =125 BPM. THE RCS REVIEWED THE ECG/ARRHYTHMIA HEART RATE ALARM STRUCTURE AND EXPLAINED TO THE BIOMED THAT THE PATIENT'S HEART RATE WAS WITHIN NORMAL LIMITS BASED ON THE CURRENT CONFIGURATION. AS A RESULT, THE MONITOR WOULD NOT HAVE ACTIVATED A YELLOW (*) OR RED (**) ALARM. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS, AND THE CAUSE OF THE REPORTED PROBLEM WAS THE CUSTOMER NOT UNDERSTANDING ALARM CONFIGURATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MONITOR DID NOT GENERATE AN ALARM FOR A HIGH HEART RATE. 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
    83268 INTELLIVUE PATIENT MONITOR MX700 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700 00884838029088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown