BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 17641328 · Received August 29, 2023

    Report

    Report Number
    3003768277-2023-04672
    Event Type
    Death
    Date Received
    August 29, 2023
    Date of Event
    August 16, 2023
    Report Date
    July 31, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Removal / Correction Number
    Z-0861-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTL NARRATIVE: PHILIPS HAS ANALYZED THE DEVICE LOG FILES AND SIMULATED THE REPORTED PROBLEM IN THE TEST LAB. BASED ON THIS ANALYSIS PHILIPS HAS, IN COLLABORATION WITH THE LEGAL MANUFACTURER OF THE TABLE, IDENTIFIED A SOFTWARE ISSUE WHICH IMPACTS THE GEOMETRY MOVEMENTS OF THE PHILIPS AZURION 7 AND THE MAGNUS MAQUETTE TABLE. THE ISSUE HAS BEEN ESCALATED TO CAPA FOR THE CAUSE DETERMINATION AND CORRECTIVE ACTION(S), INCLUDING ACTIONS TO ADDRESS THIS SOFTWARE ISSUE IN THE FIELD, AS APPROPRIATE. THE INVESTIGATION OF THE INCIDENT IS PROGRESSING.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, WITHIN FIVE MINUTES OF THE START OF A PLANNED CARDIAC INVASIVE PROCEDURE, SYSTEM MOVEMENTS WERE NOT AVAILABLE, AND THE SYSTEM COULD NOT BE MOVED TO THE DESIRED POSITION. THE PHYSICIAN ELECTED TO DISCONTINUE THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND SUBSEQUENTLY DIED. PHILIPS COMPLETED A GOOD FAITH EFFORT TO ACQUIRE FURTHER INFORMATION REGARDING THE SEQUENCE OF EVENTS AND THE CIRCUMSTANCES OF THE PATIENT¿S DEATH, BUT NO FURTHER DETAILS WERE PROVIDED. DUE TO THIS, PHILIPS HAS NOT BEEN ABLE TO DRAW A CONCLUSION AS TO WHETHER THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PHILIPS SYSTEM AND THE REPORTED PATIENT OUTCOME. A PHILIPS FIELD SERVICE ENGINEER (FSE) AND THE MAQUETTE TABLE REPRESENTATIVE INSPECTED THE SYSTEM ON SITE. THE TABLE COMMUNICATION CONTROLLER AND COMMUNICATION HUB WERE REPLACED, AND THE TABLE SOFTWARE WAS RECONFIGURED. AFTER SERVICE WAS PERFORMED, THERE WERE NO FURTHER REPORTED OCCURRENCES OF THIS ISSUE. AN ANALYSIS OF SYSTEM LOG FILES FROM THE DATE OF THE OCCURRENCE CONFIRMED THAT THE REPORTED ISSUE WAS DUE TO A COMMUNICATION ISSUE BETWEEN THE PHILIPS AZURION 7M20 FLEXARM SYSTEM AND THE MAGNUS MAQUETTE TABLE. WHEN THE DETECTOR IS POSITIONED APPROXIMATELY 4CM FROM THE PATIENT, A SOFTWARE ISSUE MAY CAUSE THE CONNECTION BETWEEN THE FLEXARM SYSTEM AND THE TABLE TO BE LOST. IF THE DETECTOR REMAINS AT A 4CM DISTANCE FROM THE PATIENT WHEN THE TABLE RESTARTS, THE CONNECTION BETWEEN THE FLEXARM AND THE TABLE MAY NOT BE RE-ESTABLISHED. THIS MAY LEAD TO A RECURRING CONNECTION LOSS, RESULTING IN UNAVAILABLE TABLE MOVEMENTS, AND IN SOME CASES, UNAVAILABLE MOTORIZED FLEXARM MOVEMENTS. WHEN THE FLEXARM MOVEMENTS ARE UNAVAILABLE, USER MESSAGES INDICATING A TABLE COLLISION ARE PROMPTED BY THE FLEXARM SYSTEM. PHILIPS HAS INITIATED A FIELD SAFETY CORRECTIVE ACTION (Z-0861-2024) FOR THIS ISSUE. THE CORRECTION HAS BEEN IMPLEMENTED AT THE CUSTOMER, AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT AN AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE MAGNUS MAQUETTE TABLE AND THE AZURION DEVICE. THE SYSTEM WAS IN CLINICAL USE AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SENT SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185480 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death