BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 19435729 · Received May 31, 2024

    Report

    Report Number
    1218950-2024-00397
    Event Type
    Death
    Date Received
    May 31, 2024
    Date of Event
    April 28, 2024
    Report Date
    May 31, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS TECHNICAL CONSULTANT (TC) WENT TO THE CUSTOMER SITE, AND CHECKED THE MX40 DEVICE; IT WAS FOUND TO BE WORKING CORRECTLY. THE TC LOGGED INTO THE PRIMARY SERVER, AND DOWNLOADED THE DEVICE REPORT, LOGS AND CLONE CONFIGURATION. A PHILIPS CLINICAL PRODUCT SPECIALIST (CAS) REVIEWED THE INFORMATION PROVIDED. BASED ON THE INFORMATION PROVIDED, THE FOLLOWING DETERMINATION WAS MADE: THE DEVICE WAS PUT INTO STANDBY FOR A REPORTED PROCEDURE AND THEN RETURNED. THE CUSTOMER INDICATED THAT THE TELEMETRY DEVICE WAS PLACED BACK ON THE PATIENT ¿AROUND 6:30 AM¿, BUT THE MX40 PWM LOGS INDICATE THAT THEY DID NOT PRESS THE BUTTON UNTIL 7:16:14. DURING THE COURSE OF THIS INVESTIGATION, IT WAS NOTED THAT THIS HOSPITAL IS NOT ON THE LATEST MX40 SOFTWARE, WHICH COULD HAVE AUTO RESUMED FROM STANDBY AT OR AROUND 6:40, IF THE REPORTED TIMELINE IS CORRECT, AND LIKELY ALARMED BEFORE THE ASYSTOLE AT 7:16:28. IN MAY2023, A LETTER WAS SENT TO ALL CUSTOMERS TO REMIND THEM TO REVIEW THE INFORMATION IN THE INTELLIVUE MX40 INSTRUCTIONS FOR USE (IFU) ON HOW TO USE STANDBY MODE AND TO EXPLAIN UNDER WHAT CIRCUMSTANCES, USE OF OR EXPOSURE TO THE DEVICE MAY POSE A RISK OF HARM. THE NOTIFICATION ALERTS USERS OF THE ASSOCIATED RISK OF USING STANDBY MODE AND STEPS TO BE TAKEN TO REDUCE OR ELIMINATE THE RISK. IN AUGUST 2023, A SERVICE BULLETIN WAS RELEASED FOR CUSTOMER NOTIFICATION. THIS SERVICE BULLETIN ANNOUNCED THE AVAILABILITY OF INTELLIVUE MX40 SOFTWARE REVISIONS B.06.86 AND C.01.86. INVOLVING STANDBY ENHANCEMENTS. LASTLY, AN FCO-SERVICE RECOMMENDATION WAS RELEASED ON 05FEB2024 NOTING THE ENHANCEMENT TO THE MX40 PWM STANDBY MODE FUNCTIONALITY THAT WAS MADE IN SOFTWARE REVISIONS B.06.86 AND C.01.86. THIS NEW SOFTWARE WAS BEING PROVIDED TO ANY CUSTOMER WHO REQUESTS IT. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE MX40 BEING PLACED INTO STANDBY MODE, BUT NOT REMOVED FROM STANDBY AFTER IT WAS PLACED BACK ON THE PATIENT AROUND 6:30 UNTIL 7:16:14. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A PATIENT INCIDENT AND THE PATIENT PASSED AWAY WHILE BEING MONITORED WITH THE DEVICE. THE STAFF STATED THE AUDIBLE ALARM DID NOT SOUND DURING THE PATIENT EPISODE. THE CUSTOMER REQUESTED ASSISTANCE IN DETERMINING WHETHER THE DEVICE WAS WORKING PROPERLY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. THIS RECORD IS RELATED TO MFR REPORT NUMBER 1218950-2024-00398.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399418 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death