BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2171866 · Received July 22, 2011

    Report

    Report Number
    1628664-2011-00536
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ARCHITECT I2000 IS CERTIFIED TO THE APPROPRIATE (B)(4) SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE. THE OBJECTIVE OF THE SAFETY STANDARDS AS RELATED TO FIRE "IS TO ENSURE THAT THE DESIGN AND METHODS OF CONSTRUCTION PROVIDE ADEQUATE PROTECTION FOR THE OPERATOR AND THE SURROUNDING AREAS AGAINST SPREAD OF FIRE FROM THE EQUIPMENT". THERE SHALL BE NO SPREAD OF FIRE OUTSIDE THE EQUIPMENT IN NORMAL CONDITIONS OR IN SINGLE FAULT CONDITION. ABBOTT'S EQUIPMENT IN MOST CASES PROVIDES REDUNDANT PROTECTION AGAINST FIRE. IN ADDITION, THE SAFETY STANDARDS REQUIRE DOUBLE PROTECTION AGAINST ELECTRIC SHOCK. A COMPLAINT SEARCH DID NOT FIND ANY ADDITIONAL INCIDENTS WHERE SMOKE WAS EMITTED FROM THE MONITOR ATTACHED TO THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4). BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS FOUND FOR THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INSTRUCTIONS INVOLVING ELECTRICAL AND CHEMICAL HAZARDS AND PROVIDES AN EMERGENCY SHUTDOWN PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT VISIBLE SMOKE WAS OBSERVED COMING FROM THE ARCHITECT I2000SR MONITOR WHEN IT WAS TURNED ON. THE CUSTOMER SUCCESSFULLY REPLACED THE MONITOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1