BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20575434 · Received October 30, 2024

    Report

    Report Number
    3003768277-2024-06232
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 20, 2024
    Report Date
    November 21, 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
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THERE WAS A GEOMETRY MOVEMENT ERROR. THE FSE ANALYSED THE LOG FILE, CHECKED AMC AND DOWNLOADED BOARD SOFTWARE. UPON FURTHER TROUBLESHOOTING, THE FSE PLUGGED AND UNPLUGGED THE CABLE TO THE COMMUNICATION BOARD AND ADJUSTED HEP AND HLP POSITIONS. AFTER THE REPAIR, 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 GEOMETRY MOVEMENTS WERE UNAVAILABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011927 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