BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18824851 · Received March 4, 2024

    Report

    Report Number
    3003768277-2024-01504
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 23, 2024
    Report Date
    September 25, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ANALYSIS OF THE LOG FILES INDICATED THAT PARTS OF THE POWER DISTRIBUTION UNIT (PDU) WERE MALFUNCTIONING. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED EVENT. DURING TROUBLESHOOTING, FSE FOUND THAT THERE WERE NO LEDS AND NO 230-VOLT POWER COMING FROM SINGLE-PHASE UNINTERRUPTIBLE POWER SUPPLY(UPS) OF THE FAN AND POWER TRAY. FSE CONFIRMED THAT THE FAN AND POWER TRAY, PDU DIRECT CURRENT MODULE AND PDU CONTROL MODULE WERE DEFECTIVE AND REPLACED THEM. ALSO, THE SOFTWARE TO THE PDU CONTROLLER WAS OVERDRIVEN, WHICH RESOLVED THE ISSUE. THE REPLACED FAN AND POWER TRAY, PDU DIRECT CURRENT MODULE AND PDU CONTROL MODULE WERE RETURNED FOR ANALYSIS. PART ANALYSIS OF PDU FAN AND POWER TRAY INDICATED THAT THE FAILED COMPONENT WAS POWER SUPPLY UNIT (PSU) AND CAUSE OF THE ISSUE WAS ELECTRICAL OVERSTRESS DUE TO ABNORMAL USE BY CUSTOMER. THE CAUSE OF THE PDU DIRECT CURRENT MODULE AND PDU CONTROL MODULE COULD NOT BE CONCLUSIVELY DETERMINED BY THE SUPPLIER'S PART ANALYSIS. AFTER REPLACING THE FAN AND POWER TRAY, PDU DIRECT CURRENT MODULE AND PDU CONTROL MODULE, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE AZURION SYSTEM WOULD NOT TURN ON. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE POWER SUPPLY. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194751 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