BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2192377 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04239
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, BEC FIELD SERVICE ENGINEER (FSE) VISITED THE SITE. THE FSE REMOVED THE SIDE COVER AND FOUND A MELTED CABLE HEAD AND BURN MARK ON THE ISOLATRAN ASSEMBLY. THE FSE ORDERED PARTS TO COMPLETE REPAIRS. ON (B)(6) 2011, THE FSE REPLACED THE AC OUTPUT HARNESS ASSEMBLY AND THE 3K VA TOROIDAL LINE CONDITIONER, ROHS (POWER TRANSFORMER). POWER TRANSFORMER WAS REPLACED SINCE CONNECTION INPUT WAS ALSO AFFECTED AND EVIDENCE OF ARKING WAS VISIBLE. THE FSE TESTED THE INSTRUMENT MECHANICALLY AND ALL TEMPERATURES WERE WITHIN THE SPECIFICATION. THE CUSTOMER WAS TO DISCARD ON BOARD CARTRIDGE CHEMISTRY REAGENTS AND LOAD FRESH REAGENTS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED SMOKE AND SPARKS ALONG WITH A LOUD NOISE OBSERVED ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER IMMEDIATELY POWERED DOWN THE INSTRUMENT AND THE COMPUTER. THE CUSTOMER DID NOT PULL THE FIRE ALARM AND THE FIRE DEPARTMENT WAS NOT NOTIFIED. PER CUSTOMER, NO ONE IN THE ROOM WAS AFFECTED BY THE SMOKE AND THE BURNING RUBBER SMELL, AND NO ONE SOUGHT MEDICAL ATTENTION. THE CUSTOMER STATED THAT THE FACILITY HAS A WRITTEN EXPOSURE CONTROL PLAN. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO UNPLUG THE INSTRUMENT AND THE COMPUTER, AND GENERATED AN AFTER HOURS SERVICE TASK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1