BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD10

    MDR report key: 8674388 · Received June 6, 2019

    Report

    Report Number
    3003768277-2019-00047
    Event Type
    Death
    Date Received
    June 6, 2019
    Date of Event
    May 30, 2019
    Report Date
    May 31, 2019
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS HAS CONFIRMED THAT A PATIENT ARRIVED WITH AN ACUTE PHASE MYOCARDIAL INFARCTION IN ORDER TO UNDERGO A REVASCULARIZATION BY PRIMARY ANGIOPLASTY ON THE PHILIPS X-RAY SYSTEM. PHILIPS INSPECTED THE HIGH VOLTAGE PLUG OF THE X-RAY TUBE AND CONCLUDED, BASED ON THE FLASH-OVER MARKS ON THE PLUG, THAT THE CAUSE OF THE NOISE AND THE ARCING WAS A FAULTY HIGH VOLTAGE (HV) PLUG CONNECTION. THE HV PLUG WAS REPLACED AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. PHILIPS HAS OPENED AN INVESTIGATION AS A FOLLOW UP FOR THE NOTED COMPLAINT. SEX OF THE PATIENT = MALE 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

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PROCEDURE THERE WAS A NOISE COMING FROM THE TUBE WHILE DELIVERING X-RAY. THE PROCEDURE CONTINUED UNTIL X-RAY WAS NOT AVAILABLE ANYMORE. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER ROOM WHERE THE PATIENT DIED. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469260 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS HEALTHCARE 722026

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death