BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA

    MDR report key: 4202699 · Received October 27, 2014

    Report

    Report Number
    1518293-2014-00134
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REGIONAL SERVICE INVESTIGATED REPORT THAT THE RAM WAS RUNNING BACKWARDS, AND FOUND CONTRAST MEDIA HAD PENETRATED POWERHEAD. SERVICE ENGINEER CLEANED CONTRAST FROM POWERHEAD, RECALIBRATED POSITION OF RAMS, AND TESTED THE UNIT FOR PROPER FUNCTION. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    (B)(6) SERVICE ENGINEER IN (B)(6) REPORTS: THE PISTON FROM THE INJECTOR RUNS SPORADICALLY IN THE WRONG DIRECTION (BACKWARD). THE PROBLEM OCCURRED DURING THE FILLING PROCESS OF THE SYRINGE. THE INJECTOR WAS IMMEDIATELY TAKEN OUT OF ORDER BY THE CUSTOMER, NO PATIENT INJURY. NO ADDITIONAL DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683039 ILLUMENA DXT DXT LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1