BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 1.4GHZ

    MDR report key: 21917646 · Received April 28, 2025

    Report

    Report Number
    1218950-2025-000269
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 7, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME WAS CORRECTED FROM MX40 1.4 GHZ SMART HOPPING TO INTELLIVUE MX40 1.4 GHZ D2B FDA PRODUCT CODE WAS CORRECTED FROM DSI TO MHX D4 MODEL NUMBER WAS CORRECTED FROM 865350 TO MX40 1.4 GHX SMART HOPPING THE PHILIPS REMOTE SERVICE ENGINEER (RSE) SENT THE CUSTOMER A QUOTE AND BENCH REPAIR FORM. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE TO BENCH REPAIR. AS OF 13JUN2025, THIS DEVICE HAS NOT BEEN RECEIVED BY THE PHILIPS AUTHORIZED REPAIR FACILITY FOR EVALUATION, THEREFORE, THE COMPLAINT ALLEGATION CANNOT BE CONFIRMED, AND THE CAUSE OF THE REPORTED ALLEGATION IS UNDETERMINED. IF ADDITIONAL INFORMATION IS LATER OBTAINED, THE COMPLAINT WILL BE REASSESSED AND UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO AUDIBLE TONES COMING FROM THE MX40 1.4 GHZ SMART HOPPING WHEN THE DEVICE WAS POWERED ON. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595836 INTELLIVUE MX40 1.4GHZ MX40 1.4 GHZ SMART HOPPING MHX PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown