BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22794554 · Received August 13, 2025

    Report

    Report Number
    3003768277-2025-007270
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099272
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 ON SITE AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO BOOT. UPON TROUBLESHOOTING, FSE FOUND THAT THE ISSUE WAS DUE TO ELECTRICAL DAMAGE RESULTING FROM A FAULT IN THE HOSPITAL'S X-RAY ON-LIGHT CABLE AND THIS ISSUE CAUSED THE PDU PENTA SWITCH MODULE, THE PDU DUAL SWITCH MODULE, AND RELATED PCB COMPONENTS TO BURN OUT. TO RESOLVE THIS ISSUE, FSE REPLACED PDU PENTA SWITCH MODULE, THE PDU DUAL SWITCH MODULE, AND ASSOCIATED PCB COMPONENTS. THE DEFECTIVE PDU PENTA SWITCH MODULE, PDU DUAL SWITCH MODULE WERE RETURNED TO PHILIPS FOR ANALYSIS. AFTER ANALYSIS OF PDU PENTA SWITCH MODULE IT WAS FOUND THE FAILURE WAS DUE TO THE REAR OF THE UNIT EXHIBITED SIGNS OF CHARRING, AND THE MAIN FUSE DISPLAYED INFINITE RESISTANCE, INDICATING THAT A SHORT CIRCUIT HAD TAKEN PLACE WHEREAS THE ANALYSIS OF PDU DUEL SWITCH MODULE CONFIRMED THE SHORT CIRCUIT; TWO FUSES WERE FOUND TO BE DAMAGED, EXHIBITING EITHER VERY HIGH OR INFINITE RESISTANCE DURING TESTING. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD CONDITION. THE CODES WERE UPDATED BASED ON INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF REPORTED EVENT. 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
    763910 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838099272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown