BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 11744208 · Received April 29, 2021

    Report

    Report Number
    3003768277-2021-10014
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 15, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE ALLEGATION OF THE CUSTOMER WAS THAT THE PATIENT DOSE WAS THREE TIMES HIGHER COMPARED TO PREVIOUS EXAMS. A PHILIPS ENGINEER INSPECTED THE SYSTEM ONSITE AND NO MALFUNCTION WAS FOUND. DOSE AND RADIATION PERFORMANCE TESTS SHOWED THAT THE SYSTEM WAS WORKING ACCORDING TO SPECIFICATION. NO IMAGE QUALITY ISSUES WERE FOUND EITHER. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO GET FURTHER INFORMATION REGARDING THE PATIENT DOSE AND PROCEDURE. HOWEVER, THE CUSTOMER HAS NOT PROVIDED THE REQUESTED INFORMATION. NO FURTHER INVESTIGATION COULD BE PERFORMED. PHILIPS CANNOT CONFIRM THE REPORTED HIGH PATIENT DOSE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PROCEDURE THE PATIENT RECEIVED A HIGH RADIATION DOSE AND IMAGES WERE BLURRY. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PROCEDURE THE PATIENT RECEIVED A HIGH RADIATION DOSE AND IMAGES WERE BLURRY. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641884 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1