BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION SERIES R1.2

    MDR report key: 8330733 · Received February 12, 2019

    Report

    Report Number
    3003768277-2019-00003
    Event Type
    Death
    Date Received
    February 12, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 17, 2019
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K172822
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. THE ANALYSIS OF THE LOG FILES SHOWED THAT THE SYSTEM DETECTED A TABLE COLLISION RESULTING IN THE MOVEMENTS BEING STOPPED. THE CUSTOMER PERFORMED A WARM RESTART AFTER WHICH MOVEMENT OF THE SYSTEM WAS AVAILABLE AGAIN . ACCORDING TO THE LOG FILES, THERE WERE NO REQUESTS FOR X-RAY BETWEEN THE COLLISION AND THE WARM RESTART OF THE SYSTEM. WHEN A COLLISION OCCURS, AND THE SYSTEM DETECTS THAT THE COLLISION CANNOT BE RESOLVED, THE SYSTEM PER DESIGN PREVENTS ANY MOVEMENTS UNLESS THE USER ACTIVATES THE SMART BODYGUARD OVERRIDE FUNCTION. IN THIS EVENT, THE OPERATOR PERFORMED A WARM RESTART INSTEAD OF ACTIVATING THE SMART BODYGUARD OVERRIDE FUNCTION. THIS FURTHER DELAYED MOVEMENT OF THE SYSTEM TO GAIN BETTER ACCESS TO THE PATIENT. THE SMART BODYGUARD OVERRIDE FUNCTION IS DESCRIBED IN CHAPTER 3.1.5 OF THE INSTRUCTIONS FOR USE OF THE SYSTEM [452220352422 AZURION RELEASE 1.2]. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED THROUGH THE ANALYSIS OF THE LOG FILES. THE PREVENTIVE MAINTENANCE OF THE SYSTEM PERFORMED BY PHILIPS ON MARCH 27TH, 2019 CONFIRMED THAT THE SYSTEM IS ACCORDING TO SPECIFICATIONS. NO FURTHER ACTIONS WILL BE TAKEN BY PHILIPS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING THE RESUSCITATION OF A PATIENT, THE USER PUSHED THE PAN HANDLE TO MOVE THE PATIENT AND WHEN DOING THE RESUSCITATION AS THE TABLE WAS IN RELEASE STATE, THE TABLE TOP COLLIDED WITH THE TUBE. AFTER THE COLLISION NO MOVEMENT NOR SCREENING WERE POSSIBLE. THE USER PERFORMED A WARM RESTART THAT RESTORED THE SYSTEM TO FULL OPERATION. PHILIPS HAS "BEEN" REPORTED THAT THE PATIENT PASSED AWAY AFTER ONE HOUR OF RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126364 AZURION SERIES R1.2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722067

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death