PHILIPS HOLTER SOFTWARE

Additional Manufacturer Narrative

A REMOTE SERVICE ENGINEER (RSE) DETERMINED THAT WHEN USING THE XML WORKLIST IN HOLTER SOFTWARE (3.0.4), THE FOLLOWING ISSUES OCCURRED: WHEN EXPORTING THE HOLTER STUDY IN DICOM FORMAT, THE ACCESSIONID WAS LOST, AND THE PATIENT SEX (MALE OR FEMALE) IS CHANGED TO O (OTHER). THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION. THE ZHR FILE FORMAT WAS DESIGNED IN 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. 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. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THERE WAS INCORRECT ACCESSIONID HOLTER CAUSING PATIENT IMAGES TO BE MATCHED TO THE WRONG PATIENT ID. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

Additional Manufacturer Narrative

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. (B)(6).