BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 1.4GHZ

    MDR report key: 25032049 · Received April 29, 2026

    Report

    Report Number
    1218950-2026-100268
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 27, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY REMOTE CLINICAL SUPPORT (RCS) PERSONNEL WHICH INCLUDED REMOTE SUPPORT. RCS DISCUSSED THE ISSUE WITH THE CUSTOMER WHO INDICATED THEY KNEW THE MEASUREMENT WAS INCORRECT BUT DID NOT UNDERSTAND WHY. THE CUSTOMER WAS TRYING TO UNDERSTAND THE TEST RESULTS IN RELATION TO THE PACEMAKER AND WANTED TO KNOW HOW THE SOFTWARE GENERATES, CREATES, AND PLACES PACING SPIKES, ESPECIALLY WHEN THERE'S PREMATURE VENTRICULAR CONTRACTIONS (PVC). THE RCS EXPLAINED THE RESULTS AND PROVIDED INFORMATION REGARDING ST/AR ALGORITHM APPLICATION NOTES THAT EXPLAIN HOW IT WORKS. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS, AND THE CAUSE OF THE REPORTED PROBLEM WAS A LACK OF UNDERSTANDING ON HOW THE ST/AR ALGORITHM FUNCTIONS FOR PACED PATIENTS. THE ISSUE WAS RESOLVED BY PROVIDING INFORMATION REGARDING ST/AR ALGORITHM APPLICATION NOTES THAT EXPLAIN HOW IT WORKS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A MX40 1.4 GHZ SMART HOPPING INDICATING THAT THE MX40 IS SHOWING R ON T PACING, AND HE KNOWS THIS IS NOT CORRECT. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460373 INTELLIVUE MX40 1.4GHZ MX40 1.4 GHZ SMART HOPPING MHX PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1