BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19134157 · Received April 18, 2024

    Report

    Report Number
    3003768277-2024-02314
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 20, 2024
    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
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE DEVICE WAS IN DIAGNOSTIC PROCEDURE WHEN THE ISSUE OCCURRED, AND IT GOT DELAYED. THE PHILIPS DISTRIBUTOR REPORTED THAT THE SYSTEM WAS NOT SWITCHED ON AND THERE WAS NO LED INDICATION ON THE PDU CONTROL MODULE. THE DISTRIBUTOR ATTEMPTED TO REPLACE THE PDU (POWER DISTRIBUTION UNIT) FANTRAY, DCPS (DIRECT CURRENT POWER SOURCE) MODULE AND THE PDU CONTROL MODULE, BUT IT DID NOT RESOLVE THE ISSUE. DURING TROUBLESHOOTING, THE DISTRIBUTOR FOUND THAT THERE WAS DEFECTIVE PDU MODULE. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) HELPED THE DISTRIBUTOR TO ORDER THE REQUIRED PARTS AND INSTRUCTED TO FOLLOW PDU CONTROL MODULE REPAIR INSTRUCTIONS WHILE REPLACING THE PDU. TO RESOLVE THE ISSUE, THE DISTRIBUTER REPLACED THE PDU. AFTER THE 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 HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT POWER ON. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288250 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown