BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 15614353 · Received October 17, 2022

    Report

    Report Number
    3003768277-2022-00539
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 17, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085350
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION PROVIDED, THE SYSTEM WAS IN CLINICAL USE WHEN THE EVENT OCCURRED AND RESULTED IN A DELAY IN EXAMINATIONS. NO PATIENT HARM WAS REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER WHO REPORTED THAT MWM ACQUISITION COULDN'T BE DONE AFTER THE SYSTEM WAS STARTED UP AND, IN SUBSEQUENT EXAMINATIONS, THE APC COULDN'T BE USED. THE CUSTOMER RESTARTED THE SYSTEM AND ALL OPERATIONS IMPROVED WITH NO FURTHER ABNORMALITIES IN THE MWM ACQUISITION. THE CUSTOMER ALSO CHECKED THE SYSTEM LOG BUT FOUND NO ERRORS. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. AFTER RESTARTING, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT, DURING A PROCEDURE, ACQUISITION COULDN'T BE DONE AND IN SUBSEQUENT EXAMINATIONS THE APC COULDN'T BE USED. THE PROCEDURE WAS DELAY. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2933853 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838085350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown