BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20378865 · Received October 5, 2024

    Report

    Report Number
    3003768277-2024-05695
    Event Type
    Malfunction
    Date Received
    October 5, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 29, 2024
    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
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 UNABLE TO POWER ON. UPON FUNCTIONAL TESTING, THE FSE FOUND THAT THE POWER WAS GOING TO THE PDU OVERPROTECTION BOARD BUT NOT PASSING TO THE INTERFACE, SO THE FSE REPLACED THE PDU MAINS INTERFACE MODULE AND TRIED TO BOOT UP THE SYSTEM, BUT THE ISSUE PERSISTED. UPON FURTHER TESTING, THE FSE FOUND A BLOWN FUSE ON THE FAN TRAY, AND HE REPLACED IT, BUT FAN TRAY WAS STILL NOT POWERING ON WHICH CONFIRMED THE MALFUNCTION OF THE FAN TRAY. TO RESOLVE THE REPORTED ISSUE, THE FSE REPLACED THE PDU FANTRAY. BOTH THE DEFECTIVE PARTS; PDU FANTRAY AND PDU MAINS INTERFACE MODULE WERE RETURNED FOR ANALYSIS, IN WHICH THE PDU FANTRAY SHOWED DEFECT IN POWER SUPPLY UNIT (PSU01 AND PSU02), WHEREAS THE CAUSE OF PDU MAINS INTERFACE MODULE DIDN¿T CONCLUSIVELY DETERMINE HOWEVER, THE REPLACEMENT OF THE DEFECTIVE PDU FANTRAY AND PDU MAINS INTERFACE MODULE BY THE FSE RESOLVED THE REPORTED ISSUE AND RESTORED THE FUNCTIONALITY OF THE SYSTEM AFTER REPLACEMENT, THE SYSTEM WAS 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 WAS UNABLE TO POWER ON. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE 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
    713818 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown