BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE INJECTOR SYSTEM

    MDR report key: 4954287 · Received July 30, 2015

    Report

    Report Number
    1518293-2015-00070
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K984088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED INJECTOR AND FOUND THAT THE A SIDE WOULD MOVE CORRECTLY ALONE. HE ALSO FOUND THAT WHEN THE B SIDE WAS MOVED, THE A SIDE WOULD ALSO MOVE. FSE REPLACED THE DRIVER BOARD WHICH RESOLVED THE PROBLEM. FSE THEN CHECKED THE INJECTOR FOR PROPER FUNCTION PER SERVICE CHECKLIST 802848. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO THE CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS WHILE SETTING UP FOR A PATIENT (PURGING AIR FROM THE LINES), THE A SIDE WOULD MOVE CORRECTLY. WHEN THE B SIDE WAS MOVED, THE A SIDE WOULD ALSO MOVE. THIS WAS WHEN THE TUBING WAS NOT CONNECTED TO THE PATIENT AND NO SETTINGS WERE SELECTED. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498387 OPTISTAR LE INJECTOR SYSTEM OPTISTAR LE DXT LIEBEL FLARSHEIM OPTISTAR LE INJECTOR SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1