BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17630473 · Received August 28, 2023

    Report

    Report Number
    3003768277-2023-04658
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 14, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE CONFIRMED THAT THE THAT SYSTEM WOULD NOT BOOTUP AND THE SCREEN WAS BLACK. REVIEW OF SYSTEM LOG FILE IDENTIFIED THAT MULTIPLE POWER TAPS OF (POWER DISTRIBUTION UNIT) PDU WERE MALFUNCTIONING. UPON TROUBLESHOOTING, FSE IDENTIFIED THAT THE SYSTEM SHUT DOWN AUTOMATICALLY. THE FSE REPLACED THE REVIEW MODULE, THE PDU FAN TRAY AND THE PDU CONTROL MODULE AND INSTALLED SOFTWARE. THE PDU FAN TRAY WAS RETURNED TO THE PHILIPS FOR FURTHER ANALYSIS. THE FAILURE ANALYSIS CONFIRMED THE MALFUNCTION OF PDU FAN TRAY WAS DUE TO FAILED 24V POWER SUPPLY. AFTER REPLACEMENT, 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 HAS BEEN REPORTED TO PHILIPS THAT SYSTEM WAS HAVING BOOT UP ISSUES. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE REVIEW MODULE, THE PDU FAN TRAY AND DCPS AND THE PDU CONTROL MODULE. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317862 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown