BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700 ANALYZER

    MDR report key: 2072185 · Received April 28, 2011

    Report

    Report Number
    2919069-2011-00187
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR NOTICED THAT THE INTERNAL MONITOR WAS DISCONNECTED, BUT IT WAS ENCLOSED BY DESIGN. THE FSR DID NOT NOTICE ANYTHING INDICATING FIRE OR SMOKE. THE FSR INSPECTED THE MONITOR AND DID NOT NOTICE ANY BURN, SOOT, OR SCORCHED MARKS. THE LIKELY SOURCE OF THE ISSUE WAS THE ENCLOSED MONITOR. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE CELL-DYN 1700 SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE RISK MANAGEMENT FILE INDICATES THAT SYSTEM COMPONENTS ARE A POTENTIAL SOURCE OF BURNS, FIRE, OR SMOKE. CONTROLS IN PLACE TO REDUCE THE RISK ARE COVERS, OVER-CURRENT PROTECTION, FUSING, INSTRUCTIONS, SAFETY ICONS, AND HAZARD WARNING LABELS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE MONITOR ON THE CELLDYN 1700 ANALYZER MADE A POPPING SOUND AND SMOKE CAME OUT OF THE TOP SEAM OF THE ANALYZER. THE ANALYZER WAS SUBSEQUENTLY UNPLUGGED. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1