BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREEVENT

    MDR report key: 21322752 · Received February 6, 2025

    Report

    Report Number
    1218950-2025-000084
    Event Type
    Death
    Date Received
    February 6, 2025
    Date of Event
    October 31, 2024
    Report Date
    April 10, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    UDI-DI
    00884838099128
    PMA / PMN Number
    K161164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1; REPORTER INSTITUTION PHONE NUMBER (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: PHILIPS WAS NOTIFIED ON (B)(6) 2025, BUT ALL THE LOGS FROM THE EVENT DATE (31 OCT 2024) HAD BEEN OVERWRITTEN AND THE ONLY LOGS THAT COULD BE RETRIEVED WAS THE ONE COLLECTED BY THE CUSTOMER. THE FIELD SERVICE ENGINEER (FSE) PROVIDED AN ANALYSIS OF THOSE LOGS. FOR THE EVENT TABLE FOR (B)(6) 2024 BETWEEN 08:00 AND 09:00. 223 EVENTS, 0 EVENTS NOT TRANSMITTED, 22 ESCALATIONS. THE PHILIPS FIELD SERVICE ENGINEER, SUPPORT (B)(6), PHILIPS TECHNICAL MANAGER IN CHARGE AND THE CUSTOMER SENIOR BIOMEDICAL TECHNICIAN CONDUCTED PERFORMANCE VERIFICATION TESTING ONSITE. THE CUSTOMER'S ALARM CONFIGURATION OF CAREEVENT WAS TESTED AND VERIFIED. IN ADDITION, THE REVIEW STATED THAT THE "AUTO REMOVE ENDED EVENTS" FEATURE WAS UNCHECKED. AS CONFIGURED, THIS SETTING AUTOMATED THE DELETION OF COMPLETED EVENTS IN THE PHONE HISTORY, RESULTING IN THE DISAPPEARANCE OF SOME EVENTS FROM THE HISTORY. THIS COULD EXPLAIN THE CUSTOMER'S OBSERVATIONS. AFTER RESTARTING THE VIRTUAL SERVER AND CHECKING THE POINTS STATED IN THE SERVICE MANUAL, IT SHOWED THAT THE CAREEVENT SYSTEM WAS OPERATING PER SPECIFICATIONS. ALARMS THAT ARE SET TO BE SENT TO PHONES ARE BEING SENT. ESCALATIONS ARE TRIGGERED AFTER THE CONFIGURED TIME OF ONE MINUTE ON THE DEFINED PHONES. USERS DESIGNATED FOR DELEGATION ARE NOTIFIED AT THE SAME TIME AS FIRST-LEVEL USERS. THE SYSTEM STOPS SENDING NOTIFICATIONS IF USERS ARE LOGGED OUT OR IF THE PHONE IS RUNNING OUT OF BATTERY. LOGOUT/RECONNECT NOTIFICATIONS ARE GENERATED ON THE PHONE AND ARE FOUND IN THE HISTORY. NO MALFUNCTION WAS OBSERVED DURING THE TESTS. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE CUSTOMER WAS PROVIDED WITH INFORMATION FROM REVIEW. 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 THE ALARMS DID NOT RING ON THE SMARTPHONE AND REQUESTED A LOG REVIEW. THE LOGS INDICATED THAT THE ALARMS OCCURRED ON THE MONITOR AND CENTRAL STATION AND WERE TRANSMITTED TO THE SMARTPHONE. ADDITIONAL INFORMATION IS REQUESTED FOR FURTHER CLARIFICATION. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT AND A PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311598 CAREEVENT CAREEVENT MSX PHILIPS MEDICAL SYSTEMS 866435 00884838099128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death