BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2250051-2008-00594

    MDR report key: 1306263 · Received January 7, 2009

    Report

    Report Number
    2250051-2008-00594
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Product Code
    JTC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SVC ENGINEER (FSE) EVALUATED THE INSTRUMENT AND WAS UNABLE TO DUPLICATE THE ERROR. HOWEVER, THE TRACE FILE INDICATED ERROR CODE AS 129, NO WASH WATER, THE CUSTOMER RAN A VOLUME VERIFICATION WHICH PASSED ALL PARAMETERS. FSE INSPECTED THE INSTRUMENT AND FOUND NO PROBLEMS WITH INSTRUMENT'S ACCESSORIES, BUT FOUND A TIP CLAMP DIRTY. PERFORMED A COLLET CLEANING, RAN SPLLD CHECK, PRIMARY AND REAGENT RACKS, PASSED ALL PARAMETERS. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JTC

    Patients

    Seq Age Sex Outcome Treatment
    1