BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 19477279 · Received June 6, 2024

    Report

    Report Number
    1218950-2024-00416
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 17, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    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

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE IN QUESTION. THE FSE INDICATED DURING AN EVALUATION OF THE SYSTEM THAT THE PATIENT BEING MONITORED WAS NOT BEING DISPLAYED ON THE CENTRAL STATION DUE TO A LACK OF A NETWORK ACCESS POINT. THE FSE INSTALLED THE WIRELESS ACCESS POINT THAT WAS IN THE HOSPITAL CLOSET. THE FSE CONFIRMED THE ACCESS POINT IN THAT AREA INCREASED COVERAGE GREATLY AFTER INSTALL. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CUSTOMERS DEVICE ISSUE AND RESOLVED THE SYSTEM ISSUE BY INSTALLING THE HOSPITAL WIRELESS ACCESS POINT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT CODED ON THE SYSTEM. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS AN ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862985 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING MHX PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening