BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1973233 · Received January 28, 2011

    Report

    Report Number
    2050012-2011-00313
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011 AND REPLACED 36 VOLT POWER SUPPLY. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT A POPPING SOUND AND A BURNING ELECTRICAL SMELL COMING FROM UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO SMOKE OR FIRE WAS OBSERVED. BCI CUSTOMER TECHNICAL SUPPORT HAD THE CUSTOMER SHUT DOWN THE SYSTEM AND REMOVE THE REAGENTS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1