BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 1.4GHZ

    MDR report key: 22017124 · Received May 14, 2025

    Report

    Report Number
    1218950-2025-000302
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 18, 2025
    Report Date
    July 9, 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

    THE PHILIPS RESPONSE CENTER ENGINEER (RSE) PROVIDED A BENCH REPAIR QUOTE. THE CUSTOMER REFUSED BENCH REPAIR SERVICE. 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. D1. BRAND NAME WAS CORRECTED FROM MX40 1.4 GHZ SMART HOPPING TO INTELLIVUE MX40 1.4 GHZ. D2. FDA PRODUCT CODE WAS CORRECTED FROM DSI TO MHX. D4. MODEL NUMBER WAS CORRECTED FROM 865350 TO MX40 1.4 GHZ SMART HOPPING.

    Additional Manufacturer Narrative · 0

    D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEP2016 SO NO UDI REQUIRED. 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

    IT WAS REPORTED THE MX40 1.4. GHZ SMART HOPPING DEVICE HAD MALFUNCTION OF THE SPEAKER, THERE WAS NO AUDIO. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967946 INTELLIVUE MX40 1.4GHZ INTELLIVUE MX40 1.4GHZ MHX PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown