BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE, INJECTOR SYSTEM

    MDR report key: 1177873 · Received September 25, 2008

    Report

    Report Number
    1518293-2008-00287
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION PENDING. UPON RECEIPT OF INVESTIGATION SUMMARY, A MEDWATCH SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SEPTEMBER 2: RECEIVED A FAXED LF QP REPORT, "WHEN DRIP MODE-B SIDE WAS ENABLED, THE A SIDE WITH CONTRAST LOADED ALSO MOVED. FIELD SERVICE ENGINEER FOUND THAT MOVING THE B RAM, USING THE KEYBOARD, ALSO MOVED THE A RAM. NO ERROR MESSAGES. ON 9/3: CUSTOMER REPORTS ERROR 22-SYRINGE PRESSURE IS LESS THAN EXPECTED ALARM. CUSTOMER HAS NEVER EXPERIENCED THE RAM'S MOVING AT THE SAME TIME DURING ANY INJECTION PROTOCOLS. THE INJECTOR JUST SHUTS DOWN AFTER 4ML'S HAS BEEN INJECTED ON THE SALINE SIDE. NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR LE, INJECTOR SYSTEM MRI POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. OPTISTAR LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK