BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3181781 · Received June 21, 2013

    Report

    Report Number
    2919069-2013-00050
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONSISTED OF REVIEWS OF PRODUCT HISTORY AND PRODUCT LABELING, CONSULTATION WITH THE SUBJECT MATTER EXPERTS, AND INSPECTION OF THE RETURNED CPU BOARD. THE INVESTIGATION CONCLUDED THAT THE IC U200 AND TRANSIENT VOLTAGE SUPPRESSOR D200 WERE BURNED. THESE COMPONENTS WERE BURNT OUT DUE TO A HIGH SURGE OR HIGH VOLTAGE ON THE DC 24V INPUT LINE. POSSIBLE CAUSES COULD BE USAGE OF INCORRECT POWER ADAPTER (DC > 24V) OR EXTERNAL CONDITION LIKE SURGE DUE BY LIGHTNING STORM. THERE ARE NO RISKS OF FIRE ON THE CD EMERALD. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ABBOTT FIELD SERVICE ENGINEER (FSE) DISCOVERED THE CELL-DYN EMERALD CPU BOARD SHOWED SIGNS OF BEING BURNED. THE FSE WAS REPLACING THE CPU BOARD BECAUSE THE CELL-DYN EMERALD WOULD NOT TURN ON WHEN HE NOTICED THE BURNED CPU BOARD . NO OPERATOR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283509 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1