BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 10467876 · Received August 28, 2020

    Report

    Report Number
    1218950-2020-04999
    Event Type
    Death
    Date Received
    August 28, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 12, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: PHILIPS FIELD SERVICE ENGINEER (FSE), WENT ON SITE AND REVIEWED THE LOGS FOUND IN WMTS PIIC CLASSIC SERVER. REPORTING NO ISSUES FOUND. THE FSE AND BIOMED REPLACED THE AP UNIT. AND A AP CAT5E CABLE, THAT WAS FOUND TO BE DAMAGED. WHICH, RESOLVED THE CONNECTIVITY ISSUES. NO ISSUES WERE IDENTIFIED WITH THE MX40 TELEMETRY DEVICE. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE. NO FURTHER ISSUES HAVE BEEN REPORTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OCCASIONAL DROPOUTS IN THE TELEMETRY SYSTEM. THE PATIENT EXPIRED (B)(6) 2020. THE CUSTOMER STATED THEY ARE UNSURE IF DEATH OCCURRED DUE TO SYSTEM MALFUNCTION, THEY ARE INVESTIGATING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932784 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 Death