BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19977132 · Received August 13, 2024

    Report

    Report Number
    3003768277-2024-04389
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 12, 2024
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE, AND TROUBLESHOOTING FOUND THAT THE POWER DISTRIBUTION UNIT (PDU) FAN TRAY HAD NO POWER. THE ANALYSIS OF THE SYSTEM LOG FILE FOUND THAT THERE WAS A SYSTEM STARTUP ISSUE. THE FSE REPLACED THE PDU FAN TRAY AND DIRECT CURRENT POWER SUPPLY (DCPS) AND RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE ANALYSIS CONFIRMED THE MALFUNCTION OF THE PDU FAN TRAY AND DCPS AND FOUND A DEFECTIVE 24V POWER SUPPLY. FOLLOWING THE REPLACEMENT OF THE PDU FAN TRAY AND DCPS, 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 HAS BEEN REPORTED TO PHILIPS THAT THE POWER DISTRIBUTION UNIT (PDU) FAN TRAY HAD NO POWER, WHICH COULD PREVENT BOOTING. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPLACED THE PDU FANTRAY AND POWER SUPPLY (DCPS) WHICH RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176435 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