BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 24420474 · Received February 23, 2026

    Report

    Report Number
    9610816-2026-100367
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 23, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838020733
    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

    A PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE TO THE CUSTOMER AND NOTED THAT THE BIOMED PERFORMED A PIC IX SURVEILLANCE REBOOT PRIOR TO SPEAKING WITH THE RCS. THE RCS FOUND THAT THE MONITORS BED TO BED OVERVIEW APPEARS TO BE WORKING AS EXPECTED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THE DEVICE DID NOT RECEIVE A BED TO BED OVERVIEW ALARM AFTER A PATIENT'S HEART RATE DROPPED TO 40. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483090 INTELLIVUE MX800 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX800 00884838020733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown