BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3951467 · Received July 22, 2014

    Report

    Report Number
    2050012-2014-00351
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INSTRUMENT ALSO GENERATED SMART MODULE POWER FAILURE ERRORS. NO VISIBLE SMOKE, SPARKS OR FLAMES WERE OBSERVED. THERE WAS NO REPORT OF INJURY. THE FIRE DEPARTMENT WAS NOT NOTIFIED. THE LABORATORY HAS A HAZARD CONTROL PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429041 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1