BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18866608 · Received March 8, 2024

    Report

    Report Number
    3003768277-2024-01652
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 28, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 THE REPORTED PROBLEM. A REVIEW OF THE SYSTEM LOGFILES FOUND THAT THERE WAS A MALFUNCTION WITH PDU. UPON TROUBLESHOOTING ACTIONS, FSE IDENTIFIED THAT THE PDU FAN TRAY AND PDU MAIN INTERFACE MODULE WERE FAULTY. THE DEFECTIVE PDU FAN TRAY FRU AND PDU MIM (MAIN INTERFACE MODULE) FRU WERE RETURNED FOR ANALYSIS AND IT WAS CONCLUDED THAT THE 24V POWER SUPPLY WAS DEFECTIVE AND THE OVPB PCB WAS MISSING. FSE REPLACED THE PDU FAN TRAY AND THE PDU MAIN INTERFACE MODULE. 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 AZURION DEVICE WOULD NOT START UP. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE 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
    741888 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown