BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1946033 · Received January 4, 2011

    Report

    Report Number
    2050012-2010-01750
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE 36V POWER SUPPLY. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. BECKMAN COULTER SYSTEMS HAVE THE CE MARK OR UL/CSA APPROVALS WHICH MEANS THE SYSTEMS MEET THE ELECTRICAL SAFETY STANDARDS, ARE MADE OF MATERIALS THAT WILL NOT SUPPORT OR SUSTAIN COMBUSTION, AND ARE SELF EXTINGUISHING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY NOTICED A BURNING SMELL BUT NO FLAMES OR SMOKE ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. CUSTOMER ALSO NOTED POWER SUPPLY ERRORS. NO OPERATOR EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1