BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 4222215 · Received November 3, 2014

    Report

    Report Number
    2050012-2014-00491
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED A BURNT ISOLATRAN (LINE CONDITIONER) WHICH DAMAGED THE POWER HARNESS. THE FSE PROCEEDED TO REPLACE THE ISOLATRAN AND POWER HARNESS TO RESOLVE THE ISSUE. THE UNICEL DXC 800 PRO SYNCHRON SYSTEM COMPLIES WITH THE UNDERWRITERS LABORATORIES (UL), CANADIAN STANDARDS ASSOCIATION (CSA), INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC), AND EUROPEAN STANDARDS (EC) SAFETY STANDARDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING A BURNING SMELL, SPARK AND SMOKE COMING FROM THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE HOSPITAL DID NOT ACTIVATE THE FIRE ALERT AND THERE WAS NO REPORT OF ANY INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703076 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1