BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION 7 M12

    MDR report key: 7999919 · Received October 24, 2018

    Report

    Report Number
    3003768277-2018-00081
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Report Date
    September 28, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. THE REPORTED INTERMITTENT POOR IMAGE QUALITY IN A SERIES RUN RESULTED FROM AN INCORRECT CALCULATION IN THE AUTOMATIC THICKNESS CALCULATION ALGORITHM, WHICH IN TURN MAY SPECIFY AN X-RAY DOSE THAT IS TOO LOW TO PRODUCE IMAGES OF DIAGNOSTIC QUALITY. PHILIPS HAS RELEASED A NEW VERSION OF THE SYSTEM SOFTWARE THAT CORRECTS THIS ISSUE, WHICH IS BEING LOADED ONTO SYSTEMS IN THE INSTALLED BASE THROUGH A FIELD CORRECTION (FIELD CHANGE ORDER FCO 72200430). 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 HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

    Description of Event or Problem · 1

    PHILIPS HAS RECEIVED THROUGH THE (B)(6) A REPORT SUBMITTED BY A CUSTOMER. IN THIS REPORT, THE CUSTOMER STATED ¿POOR IMAGE QUALITY (GRAINY/HAZY) COMPROMISED THE PHYSICIAN'S ABILITY TO VISUALIZE THE ARTERY ADEQUATELY. REBOOTING OF SYSTEM WAS REQUIRED TO TRY TO CORRECT THE PROBLEM AND THIS RESULTED IN PROLONGED CASE TIME AND DELAYED THE DEPLOYMENT OF THE STENT. AS WELL, THIS CAUSED THE USE OF HIGHER DOSE RADIATION (25 FRAMES PER SECOND) FOR 25 MINUTES OF THE CASE WHILE CAPTURING IMAGES AND AS WELL A HIGHER DOSE (15 FRAMES PER SECOND WHICH IS DOUBLE THE CUSTOMARY DOSE OF 7.5 FRAMES PER SECOND) THROUGHOUT THE ENTIRE CASE (APPROXIMATELY TWO HOURS) FOR IDENTIFYING BLOCKAGES, LOOKING FOR DISSECTION AND PLACING STENTS. THIS RESULTED IN INCREASED RADIATION EXPOSURE TO BOTH THE PATIENT AND THE STAFF. THIS IMAGING CHAIN IS A NEW INSTALLATION THAT "BECOME" OPERATIONAL IN (B)(6) 2018. SERVICE REPRESENTATIVES FROM PHILIPS ARE AWARE OF THE ISSUE WHICH HAS BEEN TRANSIENT IN NATURE AND HAVE NOT YET IDENTIFIED A CAUSE. ISSUES WITH TRANSIENT IMAGING QUALITY HAVE BEEN IDENTIFIED AND THE PHILIPS TECHNICIANS HAVE BEEN UNABLE TO DETERMINE THE SOURCE. THIS MORNING, THE IMAGE ISSUE OCCURRED DURING A LEFT MAIN ANGIOPLASTY. THE CONSEQUENCES COULD HAVE BEEN CATASTROPHIC; HOWEVER, THE TEAM WERE ABLE TO SUCCESSFULLY COMPLETE THE CASE¿. BECAUSE OF THE ALLEGATION ON POTENTIAL HARM THIS REPORT IS BEING SUBMITTED. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840532 AZURION 7 M12 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722078

    Patients

    Seq Age Sex Outcome Treatment
    1