BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3974363 · Received August 1, 2014

    Report

    Report Number
    2050012-2014-00362
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND FOUND THAT THE WIRING HARNESS WAS BURNT. THE FSE REPLACED THE DAMAGED WIRING HARNESS AND THE LINE CONDITIONER TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACKLING SOUND AND BURNING SMELL COMING FROM THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THERE WAS NO REPORT OF INJURY OR ERRONEOUS RESULTS GENERATED. THERE WAS NO VISIBLE SMOKE, SPARKS OR FLAMES. THE FIRE DEPARTMENT WAS NOT CALLED. THE LABORATORY HAS A RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450280 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