BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 6619598 · Received June 7, 2017

    Report

    Report Number
    1518293-2017-00016
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Report Date
    June 6, 2017
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS INDICATED BY THE BIOMED THE INJECTOR PREMATURELY INJECTED AND IT IS SUSPECTED TOO MUCH CONTRAST WAS DELIVERED TO THE PATIENT. (B)(6) DISCOVERED MISSING/BROKEN PINS LOCATED ON THE J2 CONNECTOR OF THE COMMUNICATION BOARD. THIS INJECTOR IS INTERFACED WITH A (B)(6) SYSTEM. I PROVIDED THE P/N 901107-1SR TO CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401515 ANGIOMAT ILLUMENA ANGIOMAT ILLUMENA IZQ LIEBEL-FLARSHEIM 900001

    Patients

    Seq Age Sex Outcome Treatment
    1