BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2698944 · Received August 15, 2012

    Report

    Report Number
    2919069-2012-00057
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 20, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER ISOLATED THE ISSUE TO THE CELL-DYN EMERALD CPU BOARD, WHICH WAS REPLACED AND THE INSTRUMENT WAS RETURNED TO AN OPERABLE STATUS. THE RETURNED CELL-DYN EMERALD CPU BOARD WAS INVESTIGATED BY A SUBJECT MATTER EXPERT (SME). THE SME FOUND THAT THE C196 CAPACITOR HAD BURNT OFF. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE OBSERVED DAMAGE. THE SME CONCLUDED THAT VISUAL INSPECTION OF THE CELL-DYN EMERALD CPU BOARD SHOWED NO REASON FOR THE FAILURE OF THE CAPACITOR OTHER THAN AN INTERNAL FAILURE OF THE COMPONENT ITSELF. ADDITIONALLY, THE CELL-DYN EMERALD SYSTEM OPERATORS MANUAL WAS REVIEWED AND ADEQUATELY ADVISES THE OPERATOR STEPS TO TAKE WHEN AN EMERGENCY SITUATION OCCURS. BASED ON THE INVESTIGATION AND EVENT DETAILS, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE CELL-DYN EMERALD WAS SITTING IDLE FOR SEVERAL HOURS WHEN THE OPERATOR HEARD A POP AND SAW SMOKE EMITTING FROM THE INSIDE REAR OF THE CELL-DYN EMERALD. THE OPERATOR ALSO SMELLED AN ELECTRICAL BURNING ODOR. THE OPERATOR PULLED THE CELL-DYN EMERALD POWER CORD FROM THE ELECTRICAL OUTLET. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1