BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 6947739 · Received October 13, 2017

    Report

    Report Number
    1218950-2017-07185
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    September 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE DEVICE OCCURRED. EVALUATION OF THE DEVICE DEMONSTRATED WEAR AND TEAR INVOLVING THE BATTERY ADAPTOR TRAY AND THE USE OF UNAPPROVED CLEANING AGENTS. LOG FILES DEMONSTRATE THAT A LOSS OF COMMUNICATION BETWEEN THE DEVICE AND THE BATTERY OCCURRED AT 02:45 WHICH IS AT THE TIME OF THE INCIDENT AND LOGS FROM THE CENTRAL MONITOR SUPPORT THAT A NO SIGNAL INOP WAS PROVIDED AT THAT TIME WHICH WAS SILENCED AT THE CENTRAL BY A USER. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING THE ACTUAL INCIDENT THEREFORE IT COULD NOT BE CONFIRMED WHETHER OR NOT USE OF THE DEVICE WAS AN ACTUAL FACTOR IN THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED ON (B)(6) AT 2:44 AM AND THE CUSTOMER IS QUESTIONING A POSSIBLE SAFETY ISSUE INVOLVING AN MX40. DETAILS ABOUT THE INCIDENT HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726828 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