BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREEVENT

    MDR report key: 19476582 · Received June 6, 2024

    Report

    Report Number
    1218950-2024-00419
    Event Type
    Death
    Date Received
    June 6, 2024
    Date of Event
    May 25, 2024
    Report Date
    June 20, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    UDI-DI
    00884838087965
    PMA / PMN Number
    K161164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6). REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 06JUN2024. PER A PHILIPS CLINICAL RELATIONSHIP MANAGER, THE CAREEVENT SYSTEM WAS EXTENSIVELY TESTED, AND NO ISSUES WERE FOUND, AS IT IS PERFORMING ACCORDING TO SPECIFICATIONS. THE CUSTOMER WAS USING VOCERA IOS PHONES. PROVIDED LOGS WILL BE REVIEWED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RESULTS OF FUNCTIONAL TESTING INDICATE THE FOLLOWING: PHILIPS INVESTIGATED THE PHILIPS SOFTWARE, AND CONCLUDED THAT THE SYSTEM FUNCTIONED AS DESIGNED. A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS) REVIEWED ALARMS LOGS FROM THE PHILIPS PATIENT INFORMATION CENTER IX (PIC IX), AND FOUND ALARMS, INCLUDING RED ALARMS, FOR THE REPORTED BED, 3006-1. (B)(6) 2024 05:23:11 (B)(6) HOSPITAL 3006-1 3 STAR VENT FIB/TACH GENERATED AT 05:23:03. PIC IX: MRHTELECS1 RED ALARM. (B)(6) 2024 05:23:11 (B)(6) HOSPITAL 3006-1 1 STAR HR 123 >120 ENDED. PIC IX: MRHTELECS1 YELLOW ALARM. (B)(6) 2024 05:23:30 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:23:21. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:24:24 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:24:52 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:24:43. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:25:16 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:25:17 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:25:08. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:25:18 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:25:38 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:25:29. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:26:23 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:27:15 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:27:06. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:28:20 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:28:27 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:28:18. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6)2024 05:30:26 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:30:27 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG GENERATED AT 05:30:19. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:31:33 (B)(6) HOSPITAL 3006-1 CANNOT ANALYZE ECG ENDED. PIC IX: MRHTELECS1 LOGGED INOP. (B)(6) 2024 05:36:06 (B)(6) HOSPITAL 3006-1 3 STAR ASYSTOLE GENERATED AT 05:35:58. PIC IX: MRHTELECS1 RED ALARM. FURTHER INVESTIGATION BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) FOUND THAT ONE ALARM MESSAGE WAS DELIVERED FROM BED 3006-1 TO SEVEN DIFFERENT CAREEVENT / CARE ASSIST USERS. FIVE CLINICAL USERS HAD NO IPHONE DEVICES ASSIGNED SO THE ALERT WAS NOT DELIVERED TO ANY DEVICE. TWO USERS IPHONES WERE NOT AVAILABLE SO THE ALERT WAS NOT DELIVERED TO ANY DEVICE. THE RSE FOUND THAT CAREEVENT WAS WORKING IN CUSTOMER TESTING. THE RSE EXAMINED THE SYSTEM IN DETAIL, AND NOTED THAT THE CUSTOMER'S CLINICAL TEAM NEEDS TO REMEMBER TO LOGIN TO THE IPHONE TO ASSIGN THE PHONE TO THE USER IN THE CAREEVENT ASSIGNMENTS, AND THE END USERS MUST BE AVAILABLE IN THE UNIT FOR THE ALERTS TO BE RECEIVED AS EXPECTED. THE RSE FOUND THAT OVERALL THE SYSTEM IS WORKING PROPERLY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE USERS NOT BEING ASSIGNED TO THE PHONES AND/OR THE USER PHONES WERE NOT AVAILABLE IN THE CAREEVENT SYSTEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS IN PEA (PULSELESS ELECTRICAL ACTIVITY) AND THE ALARM WAS NOT ANSWERED BY THE STAFF. THE CUSTOMER REQUESTED ASSISTANCE IN DETERMINING IF THE ALERT WAS SENT THROUGH CAREEVENT TO THE NURSES' MOBILE PHONES. PER THE NURSE, THERE WERE NO ALARM NOTIFICATIONS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THE PATIENT WAS NOTED TO HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8141 CAREEVENT CAREEVENT MSX PHILIPS MEDICAL SYSTEMS 866435 00884838087965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death