BEUDAMED
    FDA Adverse Event Death Summary report: N

    VUE PACS

    MDR report key: 23183807 · Received September 30, 2025

    Report

    Report Number
    3003768277-2025-011134
    Event Type
    Death
    Date Received
    September 30, 2025
    Date of Event
    September 23, 2025
    Report Date
    February 12, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LLZ
    PMA / PMN Number
    K170580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, IT WAS REPORTED TO PHILIPS THAT DURING THE TRIAGE OF A PATIENT SUFFERING FROM A TRAUMATIC BRAIN INJURY, CEREBRAL HEMORRHAGE AND SIGNS OF INCREASED INTRACRANIAL PRESSURE, WHEN THE CUSTOMER ATTEMPTED READING PATIENT IMAGES PRIOR TO AN OPERATION, VUE PACS CLIENT DIAGNOSTIC VIEWER CRASHED SEVERAL TIMES, AND AN ERROR MESSAGE APPEARED. AFTER SEVERAL ATTEMPTS, THE IMAGES WERE AVAILABLE, AND THE PATIENT WAS TAKEN TO THE OPERATION. THE PATIENT EXPIRED SHORTLY AFTER THE OPERATION. A COMPREHENSIVE INVESTIGATION WAS CONDUCTED BY PHILIPS. THE ANALYSIS ESTABLISHED THAT A CUSTOMER NETWORK ERROR HAD A DIRECT IMPACT ON THE CLIENT WORKSTATION ABILITY TO FUNCTION. VUE PACS SERVER COMPONENT: THE SERVER OPERATED WITHIN EXPECTED PARAMETERS AND DID NOT CONTRIBUTE TO THE DELAY REPORTED IN THIS CASE. VUE PACS CLIENT COMPONENT: THE CLIENT WORKSTATION EXPERIENCED THREE SEPARATE EXTERNAL NETWORK DISCONNECTIONS DURING THE INCIDENT. WHILE THE SYSTEM PERMITTED CONTINUED READING OR ALLOWED THE USER TO LOG OUT AND LOG BACK IN, THESE EVENTS DID NOT RESULT IN ADDITIONAL TRIAGE TIME ATTRIBUTABLE TO THE DEVICE ITSELF. THE CLIENT OPERATED WITHIN EXPECTED PARAMETERS AND DID NOT CONTRIBUTE TO THE DELAY REPORTED. IMAGE TRANSFER: THE TIME REQUIRED FOR IMAGE TRANSFER FROM THE SCANNING DEVICE TO THE SERVER WAS THE PRIMARY FACTOR DICTATING THE ABILITY TO REVIEW IMAGES AND THE LENGTH OF DIAGNOSIS. IMAGES WERE TRANSFERRED IN TWO SEPARATE CYCLES. THE LOGOUT/LOGIN PROCESS DID NOT INTRODUCE FURTHER DELAYS TO THE OVERALL TRIAGE TIMELINE. BASED ON THE FINDINGS, THE INVESTIGATION CONCLUDED THAT THE PHILIPS VUE PACS CLIENT DIAGNOSTIC VIEWER FUNCTIONED AS INTENDED AND NO DEVICE MALFUNCTION IDENTIFIED. HENCE, DEVICE DID NOT CONTRIBUTE TO THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WHEN THE CUSTOMER ATTEMPTED READING PATIENT IMAGES PRIOR TO AN OPERATION, VUE PACS CLIENT DIAGNOSTIC VIEWER CRASHED SEVERAL TIMES AND AN ERROR MESSAGE APPEARED. AFTER SEVERAL ATTEMPTS, THE IMAGES WERE AVAILABLE AND THE PATIENT WAS TAKEN TO THE OPERATION. THE PATIENT EXPIRED SHORTLY AFTER THE OPERATION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336308 VUE PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VUE PACS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death