BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAGEWRITER

    MDR report key: 22204481 · Received June 13, 2025

    Report

    Report Number
    1218950-2025-000355
    Event Type
    Death
    Date Received
    June 13, 2025
    Date of Event
    April 8, 2025
    Report Date
    July 24, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    PMA / PMN Number
    K113144
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED BY A PHILIPS SENIOR PRODUCT SUPPORT ENGINEER, A PHILIPS INTEGRATION ENGINEER (IE) AND A PHILIPS SOLUTIONS ARCHITECT. THE IE PERFORMED AN ANALYSIS OF THE CONTENTS PHILIPSXML BEING SENT BY THE PIC IX C.03 SYSTEM AND WORKED WITH THE CUSTOMER¿S INTEGRATION ANALYST TO REVIEW WHAT WAS SEEN IN THE DATAMED OUTPUT. THE MONITOR DATA PATHWAY IS SUMMARIZED AS FOLLOWS: THE PHILIPS MX SERIES MONITOR SENDS THE CRITICAL VALUE STATEMENTS TO A PHILIPS PATIENT INFORMATION CENTER IX (PIC IX CENTRAL MONITORING) C.03 SYSTEM. THE PIC IX C.03 INCLUDES THESE CRITICAL VALUE STATEMENTS IN THE PHILIPS XML OF THE 12-LEAD ECG RESULT TO A THIRD-PARTY MIDDLEWARE PRODUCT 'DATAMEDFT', NOT SOLD OR DISTRIBUTED BY PHILIPS TO THIS CUSTOMER. THE CUSTOMERS PAGEWRITERTC CARTS ARE LICENSED AND CONFIGURED TO SEND DICOM FORMATTED ECG STUDIES DIRECTLY TO THE CUSTOMER'S CERNER EMR. THE INVESTIGATION DETERMINED THAT THE PHILIPS DICOM IS DESIGNED TO AND FUNCTIONS TO MEET THE UNIVERSAL DICOM STANDARDS. THIS STANDARD DOES NOT INCLUDE THE TRANSFER OF CRITICAL VALUE STATEMENTS. IN THIS CASE, THE CUSTOMER MISTAKENLY BELIEVED THAT THE CRITICAL VALUES WOULD TRANSFER TO THE CERNER EMR AND, BECAUSE OF THIS, THE USER WAS NOT ALERTED TO THE PATIENT CONDITION IN THE EXPECTED WAY. PHILIPS CARDIOGRAPH FOLLOWS THE UNIVERSAL DICOM STANDARDS AND THE PHILIPS DEVICE IS CONFORMING TO SPECIFICATIONS. AS A RESULT, THE CERNER ELECTRONIC MEDICAL RECORD DOES NOT DISPLAY THE CRITICAL VALUE STATEMENTS WHEN PAGEWRITERTC CARTS ARE LICENSED AND CONFIGURED TO SEND DICOM FORMATTED ECG STUDIES. IN SUMMARY, CERNER SOFTWARE IS NOT ABLE TO DISPLAY/PRINT CRITICAL VALUE. CERNER DOESN'T PUBLISH ITS DICOM CONFORMANCE STATEMENT FOR PHILIPS TO DO THE SYSTEM INTEGRATION. CERNER DOES NOT OPEN A CHANNEL FOR PHILIPS TO DO THE SYSTEM INTEGRATION. DICOM STANDARD DOESN'T DEFINE/RESERVE ¿DICOM TAG¿ FOR CRITICAL VALUE. ANY FURTHER CHANGES TO DICOM CAN ONLY BE PERFORMED IN COOPERATION WITH CERNER. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CLARIFIED THE ALLEGATION TO MEAN THAT THE CRITICAL VALUE STATEMENT (TEXT) IS NOT APPEARING IN THE CUSTOMER THIRD-PARTY CERNER ELECTRONIC MEDICAL RECORD (EMR) BUT IS SHOWING ON THE MX MONITOR AND PAGEWRITER TC CARTS. THE ISSUE WAS INVESTIGATED BY A PHILIPS SENIOR PRODUCT SUPPORT ENGINEER, A PHILIPS INTEGRATION ENGINEER (IE) AND A PHILIPS SOLUTIONS ARCHITECT. THE IE PERFORMED AN ANALYSIS OF THE CONTENTS PHILIPSXML BEING SENT BY THE PIC IX C.03 SYSTEM AND WORKED WITH THE CUSTOMER¿S INTEGRATION ANALYST TO REVIEW WHAT WAS SEEN IN THE DATAMED OUTPUT. THE MONITOR DATA PATHWAY IS SUMMARIZED AS FOLLOWS: THE PHILIPS MX SERIES MONITOR SENDS THE CRITICAL VALUE STATEMENTS TO A PHILIPS PATIENT INFORMATION CENTER IX (PIC IX CENTRAL MONITORING) C.03 SYSTEM. THE PIC IX C.03 INCLUDES THESE CRITICAL VALUE STATEMENTS IN THE PHILIPS XML OF THE 12-LEAD ECG RESULT TO A THIRD-PARTY MIDDLEWARE PRODUCT 'DATAMEDFT', NOT SOLD OR DISTRIBUTED BY PHILIPS TO THIS CUSTOMER. THE CUSTOMERS PAGEWRITERTC CARTS ARE LICENSED AND CONFIGURED TO SEND DICOM FORMATTED ECG STUDIES DIRECTLY TO THE CUSTOMER'S CERNER EMR. THE INVESTIGATION DETERMINED THAT THE PHILIPS DICOM IS DESIGNED TO AND FUNCTIONS TO MEET THE UNIVERSAL DICOM STANDARDS. THIS STANDARD DOES NOT INCLUDE THE TRANSFER OF CRITICAL VALUE STATEMENTS. IN THIS CASE, THE CUSTOMER MISTAKENLY BELIEVED THAT THE CRITICAL VALUES WOULD TRANSFER TO THE CERNER EMR AND, BECAUSE OF THIS, THE USER WAS NOT ALERTED TO THE PATIENT CONDITION IN THE EXPECTED WAY. GOOD FAITH EFFORTS ARE BEING MADE TO OBTAIN SERIAL NUMBER UDI INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A DISCREPANCY IN RHYTHM INTERPRETATION BETWEEN THE CARDIOGRAPH AND THE MONITOR ECG. INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THE DEVICE HAD 'BEEN A CONTRIBUTING FACTOR TO PATIENT DEATHS AND PATIENT INCIDENTS'. THE CUSTOMER CLARIFIED THE ALLEGATION TO MEAN THAT THE CRITICAL VALUE STATEMENT (TEXT) IS NOT APPEARING IN THE CUSTOMER THIRD-PARTY CERNER ELECTRONIC MEDICAL RECORD (EMR) BUT IS SHOWING ON THE MX MONITOR AND PAGEWRITER TC CARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377084 PAGEWRITER PAGEWRITER TC50 CARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death