BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19415692 · Received May 29, 2024

    Report

    Report Number
    3003768277-2024-03041
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    January 14, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) INSPECTED THE SYSTEM REMOTELY AND IDENTIFIED THE POWER DISTRIBUTION UNIT LIGHT EMITTING DIODE (LED) WAS INACTIVE. A PHILIPS FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM ON-SITE AND FOUND THE PDU FAN TRAY AND DIRECT CURRENT POWER SUPPLY (DCPS) WAS DEFECTIVE. TO RESOLVE THE ISSUE, THE FSE REPLACED THE PDU FAN TRAY, PDU FUSES OUTPUT AND PDU FUSES GENERATOR. AFTER THE REPLACEMENTS, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE PDU FAN TRAY AND DCPS WAS RETURNED TO PHILIPS FOR FURTHER ANALYSIS. IT WAS IDENTIFIED THAT POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT BOOT. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPLACED THE POWER DISTRIBUTION UNIT FAN TRAY (PDU FAN TRAY) ALONG WITH THE DC POWER SUPPLY AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939333 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown