BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HOLTER SOFTWARE

    MDR report key: 19053774 · Received April 5, 2024

    Report

    Report Number
    1218950-2024-00242
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 12, 2024
    Report Date
    May 24, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MLO
    PMA / PMN Number
    K010949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION. THE ZHR FILE FORMAT WAS DESIGNED IN AN EARLY RELEASE OF HOLTER SOFTWARE, AND THERE IS NO RESERVED SPACE FOR NEW DATA, SUCH AS THE DICOM MODALITY WORKLIST (MWL) DATA. WHEN ¿DICOM ENCAPSULATED PDF¿ WAS ADDED IN HOLTER 3.0.4 RELEASE, THE ZHR FILE FORMAT WAS NOT EXPANDED TO STORE DICOM DATA. THEREFORE, TO AVOID LOSING DICOM MWL DATA, THE CORRECT DICOM WORKFLOW WAS DETERMINED BY CHOOSING A DICOM MWL IN ¿NEW PATIENT¿ DIALOG AFTER ECG DATA IS UPLOADED FROM DTXT RECORDER AND IS ANALYZED BY CALG ALGORITHM. IT SHOULD BE EXPORTED TO DICOM SERVER DIRECTLY. IN THE ¿DICOM ENCAPSULATED PDF¿, THE PATIENT DATA ON PDF REPORT IS CORRECT. IN OTHER WORDS, WHEN THE USER OPENS, VIEWS, AND PRINTS THE DICOM ENCAPSULATED PDF REPORT, ALL THE DATA IS CORRECT. ONLY THE DATA STORED IN DICOM TAGS IS WRONG. THE RECOMMENDED WORKFLOW IS TO EXPORT DICOM PDF REPORT FIRST, THEN SAVE TO ZHR FILE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE DESIGN ISSUE OF SOFTWARE. THE REPORTED PROBLEM WAS CONFIRMED. E1 REPORTING ADDRESS POSTAL CODE: (B)(6). THE DICOM INFO MUST BE DELETED IN MEMORY WHEN THE USER CLOSES THE DOCUMENT. PHILIPS WILL CHANGE THE ZHR FILE FORMAT TO STORE DICOM MWL DATA. AFTERWARDS, THE MISMATCH WILL NOT HAPPEN ANYMORE. THE ISSUE WILL BE FULLY RESOLVED IN A FUTURE SOFTWARE RELEASE.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THERE IS A PATIENT MISMATCH IN CLINICAL HOLTER (ECG) REPORT DATA BETWEEN TWO PATIENTS IN THE PHILIPS CARDIO INTELLISPACE CARDIOVASCULAR APPLICATION. THE RESULT IS THAT THE WRONG PATIENT DATA IS MATCHED WITH THE WRONG PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448633 PHILIPS HOLTER SOFTWARE PHILIPS HOLTER SOFTWARE MLO PHILIPS MEDICAL SYSTEMS 860292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown