BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFO CENTER IX

    MDR report key: 17472217 · Received August 7, 2023

    Report

    Report Number
    1218950-2023-00537
    Event Type
    Death
    Date Received
    August 7, 2023
    Date of Event
    July 12, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PHILIPS SERVICE TEAM COLLECTED DATA ASSOCIATED WITH THIS ISSUE FOR INVESTIGATION AND VISITED THE MEDICAL FACILITY. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A FULL SITE SURVEY AND CONFIRMED THAT THE AREA, DESCRIBED AS A CANTEEN AREA, WHERE THE PATIENT COLLAPSED WAS NOT SETUP FOR PHILIPS TELEMETRY. THE FSE CONFIRMS THAT THE ACCESS POINT IN THIS AREA DID NOT HAVE PHILIPS SSID ON OR ALLOW ACCESS TO PHILIPS NETWORK. THE FSE PROACTIVELY REPLACED THE CENTRAL STATION AND UPGRADED THE SOFTWARE OF ALL MX40 DEVICES ONSITE. THE FSE ALSO ADDRESSED SOME ADDITIONAL WIRELESS SETUP AND CONFIGURATION ISSUES FOR THE CUSTOMER. THE WIRELESS ISSUES ARE NOT RELATED TO ANY MALFUNCTION OF A PHILIPS PRODUCT AND WERE ESCALATED TO THE MANUFACTURER OF THE WIRELESS ACCESS POINTS, CISCO, FOR FURTHER EVALUATION. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) AND THE RESULTS INDICATE THE FOLLOWING: THE PIC IX CLINICAL AUDIT LOGS AND STARDATE LOGS (RFDA AND DEVICE DEBUG) WERE PROVIDED. THE FOLLOWING IS WHAT WAS FOUND IN THE LOGS FOR THE INCIDENT ON 12-JUL-2023 AT 11:00 TO 12:00: THE LOGS SHOW THE FOLLOWING: 1. A BATTERY CHANGE AT 10:18 ON 12-JUL-2023 FOLLOWED BY CONNECTION TO THE NETWORK/PIC. 2. THE MX40 PWM WAS PUT INTO STANDBY AT 10:50 ON 12-JUL-2023. NOTE THAT WHILE THE DEVICE IS IN STANDBY, NO MONITORING IS BEING PERFORMED AND THERE IS NO COMMUNICATION TO THE NETWORK/PIC. 3. THE MX40 PWM WAS TAKEN OUT OF STANDBY AT 10:57 ON 12-JUL-2023. 4. SEVEN LOSSES OF COMMUNICATION BETWEEN THE MX40 PWM AND NETWORK/PIC FOLLOWED BY RE-ESTABLISHMENT OF COMMUNICATION. THESE LOSSES OF COMMUNICATION WERE NOT RELATED TO DEVICE BATTERY CHANGES. 5. WHILE THE MX40 PWM WAS COMMUNICATING WITH THE NETWORK/PIC, MEASUREMENT DATA WAS BEING ANALYZED BY THE MX40 AND **YELLOW AND ***RED ALARMS WERE BEING PROVIDED FOR * PAUSE, *HR LIMIT VIOLATIONS, PAIR PVCS, * MISSED BEAT, * NON-SUSTAINING VT, ***VTACH, *** XTACHY, ***VENT FIB/TACH, AND *** ASYSTOLE CONDITIONS. THE PERIODS WHEREIN COMMUNICATION BETWEEN THE MX40 PWM AND NETWORK/PIC OCCURRED INDICATE POSSIBLE NETWORK COVERAGE ISSUES. THE PSE FURTHER STATES THAT ALL MX40 DEVICES SOFTWARE SHOULD BE AT VERSION B.06.59 AT A MINIMUM. AS DETAILED ABOVE THE FIELD TEAM UPDATED ALL MX40 DEVICES. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS CONFIRMED AS NOT A MALFUNCTION OF A PHILIPS DEVICE. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE CENTRAL STATION WAS PROACTIVELY REPLACED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT WALKED OUT OF THE RANGE OF THE TELEMETRY WIFI AND HAD A CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657728 INTELLIVUE INFO CENTER IX INTELLIVUE INFO CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866023

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death