BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2039352 · Received April 5, 2011

    Report

    Report Number
    1628664-2011-00139
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER (FSE) WAS AT THE ACCOUNT AND PROCEEDED TO CLEAN THE CARD CAGE AND REPLACE THE 8A FUSE. WHEN THE ANALYZER WAS POWERED ON, THE FSE NOTED ANOTHER EXPLOSION SOUND. THE FSE REPLACED THE ARTESYN POWER SUPPLY QUAD MODULE BOARD (PART NUMBER 7-92696-01) WITH A PROTECTIVE CASE. THE OPTICS CHECK PASSED. TECHNICAL SERVICE BULLETIN (TSB) (B)(4) DRIP PROTECTION FOR POWER SUPPLY WAS PERFORMED ON (B)(6) 2010. A REVIEW OF THE SAFETY MEMO AND PRODUCT EVALUATION INDICATES THE ARCHITECT I2000 IS CERTIFIED TO THE APPROPRIATE US, CANADIAN, AND INTERNATIONAL SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO PROVIDE ADEQUATE INFORMATION REGARDING ELECTRICAL HAZARDS AND AN EMERGENCY SHUTDOWN PROCEDURE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THERE WAS A SMALL EXPLOSION SOUND AND LIGHT SEEN ALONG WITH SMOKE COMING FROM THE POWER SUPPLY AREA OF THE ARCHITECT I2000. THE FIELD SERVICE ENGINEER (FSE) OBSERVED A DRIP FROM THE GUTTER OVER THE POWER SUPPLY WHICH DRIPPED ONTO THE QUAD MODULE BOARD. NO FIRE WAS OBSERVED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1