BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2233723 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04762
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COUTLER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE CLEANED THE FRAME AND REMOVED THE ISOLATRAN FROM THE SYSTEM. FRESH CUVETTES WERE PLACED ON THE REACTION WHEEL BECAUSE OF THE EXTENDED DOWN TIME OF THE INSTRUMENT. THE ISOLATRAN AND ASSOCIATED COMPONENTS THAT WERE DAMAGED BY FIRE AND/OR SMOKE WERE REPLACED. UNIT WAS REASSEMBLED AND ALIGNED. QC WAS TESTED WITH NO PROBLEMS NOTED PRIOR TO RETURNING THE INSTRUMENT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) THAT THE IMMAGE IMMUNOCHEMISTRY SYSTEM CAUGHT ON FIRE. THE CUSTOMER INDICATED THAT THE FIRE DEPARTMENT WAS DISPATCHED FOR THIS EVENT. THE LABORATORY PERSONNEL WAS EVACUATED AND THE SPRINKLER SYSTEM DID NOT ENGAGE. THERE WERE NO REPORTS OF INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COUTLER INC. IMMAGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1