BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2231995 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04696
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) REPLACED A DEFECTIVE CIRCULATION FAN IN THE REACTION WHEEL CHAMBER, WHICH WAS THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT A REACTION WHEEL TEMPERATURE ERROR AFTER A PREVENTIVE MAINTENANCE. THE CUSTOMER NOTED BURNING SMELL WHEN CUVETTE COVER WAS LIFTED. THE CUSTOMER SHUT DOWN THE INSTRUMENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM NEPHELOMETER FOR CLINICAL USE JQX BECKMAN COULTER INC. IMMAGE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1