BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 11920938 · Received June 2, 2021

    Report

    Report Number
    3003768277-2021-10026
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 3, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K163715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURE NARRATIVE - PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS HAS ANALYZED THE LOG FILE AND FOUND THAT THE SYSTEM IDENTIFIED COLLISIONS WHILE THE USER WAS PERFORMING MOTORIZED FRONTAL STAND MOVEMENT. THE COLLISION ERRORS STOPPED THE C-ARM MOVEMENT AND WERE CAUSED BY MOTOR CURRENT VALUES BEING OUT OF TOLERANCE, NOT PHYSICAL COLLISIONS. A PHILIPS ENGINEER RECALIBRATED THE MOTOR CURRENTS AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT DURING A PROCEDURE, THE PHILIPS AZURION SYSTEM STOPPED RESPONDING TO MOTION CONTROLS. THE CUSTOMER MOVED THE BED INSTEAD OF THE C-ARM TO CONTINUE THE PROCEDURE. NO HARM TO THE PATIENT OR THE USER WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED THE INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818039 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other