BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 1.4GHZ

    MDR report key: 24307935 · Received February 10, 2026

    Report

    Report Number
    1218950-2026-100050
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 13, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY REMOTE CLINICAL SUPPORT (RCS) PERSONNEL WHICH INCLUDED REVIEW OF PATIENT STRIP SCREENSHOTS AND CLINICAL AUDIT LOG. THE RCS NOTED THAT THE STRIPS SHOW THE PATIENT ON TELE 20 AT 3:07:46 ON (B)(6) 2026; HOWEVER, THE PATIENT IS SHOWN TO BE ON TELE 13 AT THAT TIME ON CLINICAL AUDIT. THE RCS WAS UNABLE TO DETERMINE ANY ISSUE WITH THE MONITOR. BASED ON THE INFORMATION AVAILABLE, IT SEEMS AS THOUGH THE WRONG TELE MONITOR WAS ON THE PATIENT OR SOMETHING WAS LABELED INCORRECTLY. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED. ALTHOUGH THE CLINICAL AUDIT LOG WAS REVIEWED BY THE RCS IT WAS NOT RETAINED FOR FURTHER REVIEW. THE PRODUCT MALFUNCTION WAS UNABLE TO BE CONFIRMED BECAUSE THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION. A REVIEW OF THE SERVICE HISTORY FOR THIS DEVICE SHOWS THE PROBLEM HAS NOT BEEN REPORTED AGAIN FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A MX40 1.4 GHZ SMART HOPPING INDICATING THAT A PATIENT HAD A 17 BEAT V-TACH AND THE STAFF REPORTED THEY ONLY GOT A YELLOW ALARM AND NO RED ALARMS. 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
    369418 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 NA Unknown