BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 5074521 · Received September 14, 2015

    Report

    Report Number
    2919069-2015-00060
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 24, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). CONCOMITANT MEDICAL PRODUCTS: BACKPLANE, 6-SLOT PCA-ISA ATX, LN: 8201010001. KIT DK DRIVE STA WITH ADAPTER, LN: 9130744.

    Additional Manufacturer Narrative · 1

    PARTS WERE RETURNED FROM THE SITE OF THE INCIDENT. THESE INCLUDED THE FOLLOWING: ONE MOTHER BOARD, LIST NO. 8934107101; ONE BACKPLANE, LIST NO. 8201010001; ONE POWER SUPPLY, LIST NO. 8934107901; ONE IDE DISK DRIVE, LIST NO, 8200570701, AND ONE HARDDRIVE, LIST NO. 9130744. THE RETURNED PARTS WERE ASSESSED AND BASED ON THE INFORMATION PROVIDED, EITHER 1) A/SOME COMPONENT(S) SHORTED OR FAILED AND DREW EXCESS CURRENT THAT RESULTED IN BURNING OF THE TRACES ON THE BOARD AND COMPONENTS, OR 2) SOME COMPONENT(S) ON THE POWER SUPPLY SHORTED OR FAILED AND DREW EXCESS CURRENT THAT RESULTED IN THE BURNING OF THE TRACES AND COMPONENTS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN RUBY OPERATOR MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT ISSUE. BASED ON THE INFORMATION FROM THE EVENT SITE AND EVALUATION OF THE RETURNED PARTS, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CELL-DYN RUBY OR ITS COMPONENTS. CONCOMITANT PRODUCTS: BACKPLANE, 6-SLOT PCA-ISA ATX LN: 8201010001 DISK DRIVE, LN: 8200570701 HARD DRIVE, LN: 9130744

    Description of Event or Problem · 1

    AN ABBOTT TRAINER REPORTS THAT DURING THE START-UP PROCEDURE FOR THE CELL-DYN RUBY ANALYZER, THE ANALYZER WAS PRIMED AND A BACKGROUND CHECK WAS PERFORMED. THEN, THE ANALYZER POWERED ITSELF OFF AND A BURNING ODOR WAS NOTICED FROM THE RIGHT HAND SIDE NEAR THE FLOPPY DRIVE. THE TRAINER POWERED THE ANALYZER OFF AND UNPLUGGED IT FROM ITS POWER SOURCE. THE TRAINER REMOVED THE ANALYZER'S POWER SUPPLY AND FOUND CHARRED AND MELTED PARTS. NO OTHER DAMAGE WAS NOTED AND THERE WERE NO REPORTS OF INJURY. PRIOR TO THIS EVENT, THE ANALYZER HAD BEEN POWERED OFF FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607541 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1