BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2103221 · Received May 25, 2011

    Report

    Report Number
    1628664-2011-00240
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), CONCOMITANT MEDICAL PRODUCTS - LIST # 8-206430-01 (B)(4). AN EVALUATION WAS PERFORMED IN RESPONSE TO THE VISIBLE SMOKE AND FIRE THAT WERE OBSERVED COMING FROM THE SONICWALL TZ100, ROHS FIREWALL ADAPTER CONNECTED TO ARCHITECT I2000SR ANALYZER. THE EVALUATION CONSISTED OF A REVIEW OF COMPLAINT TEXT, A COMPLAINT SEARCH AND A REVIEW OF CURRENT ARCHITECT LABELING. AFTER THE REPLACEMENT OF THE FIREWALL ADAPTER NO ADDITIONAL OCCURRENCES OF THIS ISSUE HAVE BEEN OBSERVED. ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST ELECTRICAL SHOCK OR BURN, EXCESSIVE TEMPERATURE, SPREAD OF FIRE FROM THE EQUIPMENT, AND LIBERATED GASES, EXPLOSION AND IMPLOSION. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INSTRUCTIONS REGARDING ELECTRICAL HAZARDS AND AN EMERGENCY SHUTDOWN PROCEDURE. A REVIEW OF COMPLAINTS FOR THE TIME PERIOD OF (B)(4) 2010 THROUGH (B)(4) 2011 DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THIS ISSUE. NO SUBSEQUENT COMPLAINTS OF THIS NATURE HAVE BEEN DOCUMENTED AGAINST ARCHITECT (B)(4). BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY IN THE SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED VISIBLE SMOKE AND FIRE WERE OBSERVED COMING FROM THE ABBOTTLINK FIREWALL ADAPTER CONNECTED TO THE ARCHITECT I2000SR ANALYZER. AN ABBOTT FIELD SERVICE REPRESENTATIVE REPLACED THE FIREWALL ADAPTER TO RESOLVE THE ISSUE. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SONICWALL TZ100 FIREWALL, ROHS