BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17048910 · Received June 2, 2023

    Report

    Report Number
    3003768277-2023-03397
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 5, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SYSTEM WAS IN CLINICAL USE AND USED FOR A CORONARY DIAGNOSIS PROCEDURE. THE PROCEDURE WAS DELAYED AND COMPLETED AS PLANNED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SYSTEM ONSITE AND CONFIRMED THAT THE GEOMETRY MOVEMENTS WERE PARTIALLY UNAVAILABLE. REVIEW OF THE SYSTEM LOG FILES SHOWS A TABLE POSITION DEVIATION. UPON INVESTIGATION FSE FOUND LATERAL DRIVE WAS DEFECTIVE WHICH CAUSED TABLE ERRORS WHILE TILTING TABLE. FSE REPLACED THE LATERAL DRIVE, LATERAL POT AND REPAIRED THE BAD CONNECTION ON THE TABLE. LATER FSE FOUND LATERAL BRAKE WAS NOT RELEASING WHEN TABLE WAS TILTED. HENCE FSE REPLACED THE DEFECTIVE NODE INTERFACE UNIT (NIU) AND THE CABLES. AFTER REPLACEMENT OF NIU AND DEFECTIVE CABLES THE SYSTEM WAS RETURNED TO GOOD WORKING CONDITION. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT GEOMETRY MOVEMENTS WERE PARTIALLY UNAVAILABLE. NO PATIENT HARM WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371858 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown