BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17352848 · Received July 19, 2023

    Report

    Report Number
    3003768277-2023-04162
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 19, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099265
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE ALL POWER TURNED OFF WHILE THE SYSTEM WAS STARTING UP. REVIEW OF THE SYSTEM LOG FILE SHOWED THAT THE PDU SEEMS TO BE MALFUNCTION WHICH RESULTED IN THE SYSTEM NOT BEING ABLE TO COMPLETE THE STARTUP SEQUENCE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PDU CONTROL MODULE. AFTER REPLACEMENT OF THE PDU CONTROL MODULE, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA : PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE ALL POWER TURNED OFF WHILE THE SYSTEM WAS STARTING UP. REVIEW OF THE SYSTEM LOG FILE SHOWED THAT THE PDU SEEMS TO BE MALFUNCTION WHICH RESULTED IN THE SYSTEM NOT BEING ABLE TO COMPLETE THE STARTUP SEQUENCE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PDU CONTROL MODULE. THE PDU CONTROL MODULE HAS BEEN RETURNED FOR ANALYSIS AND INVESTIGATION CONFIRMED ELECTRONIC DEFECT IN THE PDU CONTROL MODULE. AFTER REPLACEMENT OF THE PDU CONTROL MODULE, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE ALLURA DEVICE WOULD NOT BOOT UP. THE SYSTEM WAS REBOOTED WITHOUT RESOLVE. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE PDU CONTROL MODULE. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42105 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838099265

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown