BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 20062740 · Received August 26, 2024

    Report

    Report Number
    3003768277-2024-04716
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 15, 2024
    Report Date
    December 9, 2024
    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. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE WAS USED DURING EXAMINATION. THE ASSIGNED EXAMINATION WAS POSTPONED. IT WAS REPORTED TO PHILIPS THAT SYSTEM FAILED TO START UP. REVIEW OF THE LOG FILES SHOWS MALFUNCTIONING FAN TRAY AND DCPS. UPON TROUBLESHOOTING FSE WENT ONSITE AND FOUND THAT THE INABILITY TO OPERATE THE MODULE WAS CAUSED BY A FAILURE INSIDE THE POWER SUPPLY COMPONENT THAT CONVERTS AC TO DC INSIDE THE MAIN CABINET. TO RESOLVE THE ISSUE, FSE REPLACED PDU (POWER DISTRIBUTION UNIT) FAN TRAY AND DCPS (DIRECT CURRENT POWER SUPPLY). AFTER REPLACEMENT, 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 THE SYSTEM FAILED TO START UP. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232009 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838099265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown