BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 19174884 · Received April 24, 2024

    Report

    Report Number
    1218950-2024-00295
    Event Type
    Death
    Date Received
    April 24, 2024
    Date of Event
    February 13, 2024
    Report Date
    August 8, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE DEVICE CONTEXT OF USE, EVALUATION, REPAIR, AND OPERATIONAL STATUS WITH NO RESPONSE FROM THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW INFORMATION IS OBTAINED. SERIAL NUMBER UNAVAILABLE, THEREFORE UDI IS NOT AVAILABLE AT TIME OF REPORT.

    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. (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER IS REPORTING THAT A PATIENT ON A MX40 TELE MONITOR WAS FOUND IN FULL ARREST AND IT IS UNCLEAR IF THE MONITOR WAS CAPTURING FROM 23:59 THROUGH 02:22. THE CUSTOMER STATES THAT RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. PER THE CUSTOMER, IT IS UNKNOWN WHETHER USER ERROR OR DEVICE ERROR CONTRIBUTED TO THE PATIENT OUTCOME. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT CAPTURING THE PATIENT RESULTING IN A PATIENT DEATH. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083840 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death