BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATE 800 SAMPLE PROCESSING SYSTEM

    MDR report key: 2052397 · Received April 12, 2011

    Report

    Report Number
    2050012-2011-01070
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVENT, THE CUSTOMER DISCONNECTED THE UPS AND IS RUNNING THE AUTOMATE FROM HOUSE CURRENT. THE UPS UNIT IS INSTALLED BY BCI, BUT IS NOT A BCI PRODUCT; THE UPS UNIT IS A POWERVAR PRODUCT. BCI DOES NOT SERVICE THE UPS UNITS. BCI SERVICE NOTIFIED POWERVAR AND REQUESTED TO VISIT THE CUSTOMER AND SERVICE OR REPLACE THE UPS UNITS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNINTERRUPTED POWER SUPPLY (UPS) CONNECTED TO THE AUTOMATE 800 SYSTEM FAILED CAUSING SMOKE AND FLAMES COMING FROM THE POWER SUPPLY, WHICH LED TO A CALL TO THE FIRE DEPARTMENT. THERE WAS NO OPERATOR EXPOSURE TO SMOKE REPORTED AND NO DAMAGE TO THE AUTOMATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATE 800 SAMPLE PROCESSING SYSTEM SAMPLE PROCESSING SYSTEM JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1