BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2221861 · Received August 24, 2011

    Report

    Report Number
    2050012-2011-04743
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) HAD THE CUSTOMER TURN THE POWER OFF TO THE INSTRUMENT AND CPU AND RECOMMENDED THAT THEY BE LEFT OFF. CTS ADVISED THAT AN ELECTRICAL PROBLEM MAY HAVE DEVELOPED OR A POWER SUPPLY MAY HAVE GONE OUT AND SUGGESTED SERVICE AND SET UP A SERVICE CALL. THE SERVICE CALL WAS LATER CANCELLED BY THE CUSTOMER. THE BEC INTERNAL DENTIFER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNIT WAS REBOOTING AND A POPPING NOISE FOLLOWED BY AN ELECTRICAL SMELL WAS COMING FROM THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO FLAMES OR SMOKE WAS OBSERVED. THE MONITOR SCREEN WAS BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1