BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20354928 · Received October 2, 2024

    Report

    Report Number
    3003768277-2024-05598
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 21, 2024
    Report Date
    February 13, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085367
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO O HE ADDITIONAL INFORMATION COLLECTED, PLANNED PERIPHERAL SURGERY TREATMENT WAS PERFORMED BY THE CUSTOMER AND THE PROCEDURE WAS COMPLETED BY USING FLUOROSCOPY WITH LOWER DOSE. PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THIS SYSTEM ONSITE AND FOUND THAT THE SYSTEM COULDN¿T EMIT RADIATION. FSE REVIEWED THE LOG FILE. UPON TROUBLESHOOTING, FSE FOUND THAT THERE WAS FAILURE IN EQUIPMENT TUBE AND THE CURRENT WAS OUT OF RANGE. TO RESOLVE HIS ISSUE, FSE REPLACED X-RAY TUBE AND PERFORMED REQUIRED CALIBRATION. THE DEFECTIVE PART WAS RETURNED TO PHILIPS FOR ANALYSIS AND FOUND THAT X-RAY TUBE FAILED AS THERE WAS VACCUME LEAKAGE. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM PRODUCED ERROR MESSAGES AND DID NOT EMIT X-RAYS. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. 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
    53207 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838085367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown