BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD

    MDR report key: 18456916 · Received January 5, 2024

    Report

    Report Number
    3003768277-2024-00077
    Event Type
    Death
    Date Received
    January 5, 2024
    Date of Event
    December 11, 2023
    Report Date
    July 31, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, THE PATIENT WAS BEING TREATED FOR AN EMERGENCY CARDIOVASCULAR PROCEDURE, WHICH WAS COMPLETED BY RESTARTING THE SYSTEM AND DELETING OLDER EXAMINATIONS TO FREE STORAGE SPACE FOR NEW EXPOSURE IMAGES. THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY DURING THE PROCEDURE BUT THAT THE ISSUE EXPERIENCED ON THE PHILIPS SYSTEM DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. LOG FILE ANALYSIS AND ONSITE INSPECTION IDENTIFIED THAT AN ISSUE WITH THE AUTOMATIC DELETION OF PATIENT EXAMINATIONS WAS CAUSING THE SYSTEM TO NOT PERFORM EXPOSURE IMAGES DUE TO INSUFFICIENT DISK SPACE. INVESTIGATION SHOWED THAT PATIENT EXAMINATIONS WERE ONLY ATTAINING THE ¿CLOSED¿ STATUS RATHER THAN THE ¿COMPLETED¿ STATUS, WHICH CAUSED COMPLETED PATIENT EXAMINATIONS TO NOT BE RELEASED FOR DELETION IN THE PATIENT DATABASE WHEN STORAGE SPACE WAS NEEDED. THIS WAS DUE TO A PROBLEM IN THE MPPS (MODALITY PERFORMED PROCEDURE STEP) DATA TRANSFERRING BETWEEN THE SYSTEM AND THE HOSPITAL¿S RADIOLOGY INFORMATION SYSTEM (RIS). DURING THE ONSITE VISIT, THE PHILIPS FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE SYSTEM WAS WORKING NORMALLY AND HAD SUFFICIENT SPACE AVAILABLE DUE TO THE MANUAL DELETION OF PATIENTS/IMAGES. THE CUSTOMER INFORMED PHILIPS THAT THEIR INTERNAL IT DEPARTMENT WAS WORKING TO RESOLVE THE MPPS ISSUE ON THEIR RIS SYSTEM. AFTER INFORMING THE CUSTOMER THAT IMAGES COULD BE MANUALLY DELETED ON THE SYSTEM TO FREE UP SPACE SHOULD THE ISSUE REOCCUR WHILE THE RIS PROBLEM WAS BEING RESOLVED, PHILIPS RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER. TO DATE, NO FURTHER OCCURRENCE OF THIS ISSUE HAS BEEN REPORTED. PHILIPS ANALYZED RECENT SYSTEM LOG FILES AND FOUND NO ISSUES WITH THE MPPS DATA. PATIENT OUTCOME CODE & HEALTH IMPACT CODE WAS CORRECTED. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING AN EMERGENCY EXAMINATION THE ALLURA DEVICE DISPLAYED THE ERROR MESSAGE "EXPOSURE NOT POSSIBLE. IMAGE DISK FULL" AND WOULD NOT EXPOSE. A SYSTEM RESTART WAS CONDUCTED TO RESOLVE THE ISSUE, AND THE PROCEDURE WAS CONTINUED. THE PATIENT PASSED AWAY DUE TO AN ACUTE HEART ATTACK. IT IS UNKNOWN IF THE DELAY IMPACTED THE PATIENT¿S CONDITION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676025 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death