BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® SYSTEM

    MDR report key: 2143695 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02529
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED THE SITE ON (B)(4) 2011 AND CONFIRMED VOLTAGE TO UPS, CHECKED FUSES, RECONNECTED ALL DEVICES TO UPS AND POWERED UP. DURING STARTUP, UPS BEGAN ALARMING. THE FIELD SERVICE ENGINEER (FSE) CONTACTED SUPPORT AND WAS TOLD BATTERIES WERE TO BE REPLACED. THE CUSTOMER WAS TO ORDER IN BATTERY SET AND REPLACE. THE FSE CONNECTED INSTRUMENT TO WALL. NO FURTHER BURNING SMELL COMPLAINT HAD BEEN FILED AS OF (B)(4) 2011.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A BURNING SMELL COMING FROM THE CPU OF UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER NOTICED THAT THE MONITOR WAS BLANK. THE CUSTOMER INSPECTED THE CPU AND NOTICED THAT THE CPU WAS OFF. THE CUSTOMER TURNED THE CPU ON AND WATCHED THE SYSTEM REBOOT, BUT A FEW SECONDS LATER, THE CPU TURNED OFF ON ITS OWN AGAIN, AND THE UPS WAS OFF AS WELL. THE CUSTOMER STATED THAT A WRITTEN EXPOSURE CONTROL PLAN IS IN PLACE. THERE WAS NO SMOKE, AND THE CUSTOMER WAS NOT IN ANY WAY AFFECTED BY THE SMELL AND DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1