BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 3770305 · Received February 18, 2014

    Report

    Report Number
    1518293-2014-00016
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    Manufacturer
    LIEBELFLARSHEIM COMPANY
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THE INJECTOR INJECTED ON ITS OWN WITHOUT BEING STARTED BY THE STAFF. FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE PROBLEM. INJECTOR'S PROPER OPERATION WAS VERIFIED.

    Description of Event or Problem · 1

    (B)(4) 2014, RISK MANAGEMENT REPORTS VIA PHONE ISSUES OCCURRED WITH A PATIENT WAS NOT CONNECTED TO THE INJECTOR. WHEN THE STAFF WAS MOVING THE INJECTOR INTO PLACE, THE INJECTOR EXECUTED AN INJECTION. THE CONTRAST WENT UP AND HIT THE CEILING AND ALSO ONTO THE STERILE FIELD. NO INJURIES WERE REPORTED. RISK MANAGEMENT REPORTS IT IS NOT CLEAR IF THE INJECTOR INJECTED BY ITSELF OR IF STAFF HIT BUTTON CAUSING IT TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101874 ANGIOMAT ILLUMENA DXT LIEBELFLARSHEIM COMPANY ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK