BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17298118 · Received July 11, 2023

    Report

    Report Number
    3003768277-2023-03990
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 28, 2023
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT STARTING. REVIEW OF THE LOGFILE SHOWED POWER ISSUES. THE FSE REPLACED THE PDU FAN TRAY, DCPS, AND PDU FUSES. AFTER REPLACEMENT OF THE PDU FAN TRAY, DCPS, AND PDU FUSES, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT BOOT UP AFTER IT WAS INITIALLY SWITCHED OFF. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPLACED THE PDU FAN TRAY AND DCPS AS WELL AS THE PDU FUSES. SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587721 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown