BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD SYSTEM

    MDR report key: 15462683 · Received September 22, 2022

    Report

    Report Number
    2919069-2022-00029
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 30, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020088
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND REMOVED THE CPU BOARD, PART NUMBER 8701686907 AND VISUALLY INSPECTED IT AND VERIFIED THERE WERE NO DAMAGED COMPONENTS OR SIGNS OF FIRE. CPU BOARD WAS REINSTALLED, AND INSTRUMENT IS UP AND RUNNING WITHOUT ANY ISSUES. THERE WAS NO FIRE OR SMOKE WAS SEEN NOR ANY DAMAGE TO THE INSTRUMENT. THERE WAS NO INJURY TO PERSONNEL REPORTED. A REVIEW OF THE SERVICE HISTORY FOR THE CELL DYN EMERALD ANALYZER REVEALED NO ADDITIONAL ISSUES WERE REPORTED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE CELL DYN EMERALD ANALYZER OR CPU BOARD. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CPU BOARD OR THE CELL DYN EMERALD ANALYZER WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED SMOKE FROM OUTLET ON THE SIDE OF THE INSTRUMENT WHERE THE REAGENTS ARE LOCATED ON CELL-DYN EMERALD ANALYZER. THE CUSTOMER SMELLED BURNT SMELL. THE SCREEN OF ANALYZER BLACKED OUT. THERE WAS NO VISIBLE FIRE OR SPARK. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2738124 CELL-DYN EMERALD SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 09H39-01 00380740020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown