BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17622423 · Received August 25, 2023

    Report

    Report Number
    3003768277-2023-04647
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    July 28, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K181830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE PDU (POWER DISTRIBUTION UNIT) MAINS INTERFACE MODULE AND PDU FAN TRAY. THE FSE REPLACED THE PDU MAINS INTERFACE MODULE ALONG WITH THE PDU FAN TRAY AND RETURNED THE SYSTEM 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 SYSTEM WAS NOT TURNING ON. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPLACED THE PDU (POWER DISTRIBUTION UNIT) FAN TRAY AND DCPS AND THE PDU MAINS INTERFACE MODULE, WHICH RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283408 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown