BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20137185 · Received September 4, 2024

    Report

    Report Number
    3003768277-2024-04901
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 3, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K181830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS USED DURING DIAGNOSTIC CARDIAC CHAMBERS (CONGENITAL STRUCTURAL HEART) PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT. REVIEW OF THE LOG FILES SHOWS REMOTE ALERT ¿IXR-PRO-AZURION-LEVEL-1-QUALITY-ASSURANCE PERFORMANCE VERIFICATION TEST FAILED: ENERGY AND SIGNAL FLOW 1 FRONTAL¿. UPON TROUBLESHOOTING, THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED ONSITE AND FOUND BAD DETECTOR CALIBRATIONS. FSE RAN IQ TEST, BUT IT FAILED. TO RESOLVE THE ISSUE, FSE RAN THE GAIN CALIBRATIONS AND VERIFIED IMAGE QUALITY SIGNAL FLOW. AFTER REPAIRS, THE SYSTEM 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 SYSTEM WAS UNABLE TO BOOT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187072 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown