BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1354892 · Received April 3, 2009

    Report

    Report Number
    1628664-2009-00140
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 1, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARCHITECT SCC CPU. THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF AN INVESTIGATION. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). LIST#: 7D01-03 PART#: 7-99026-01 SCC CPU (B)(4). ONLY THE POWER SUPPLY FOR SCC CPU (B)(4) WAS RECEIVED AND INVESTIGATED FOR THIS EVALUATION. THE POWER SUPPLY HAD SMOKE RESIDUE ON THE OUTER COVER AND ON THE INSIDE OF THE HOUSING. THE INNER FAN BLADE WAS MELTED AND WOULD NOT TURN. RETURNED MATERIAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE RETURNED POWER SUPPLY. AN ABBOTT FIELD SERVICE REPRESENTATIVE INSTALLED A NEW POWER SUPPLY TO RESTORE OPERATION TO THE CUSTOMER'S ARCHITECT C8000 ANALYZER. A REVIEW OF THE COMPLAINT HISTORY FOR THIS ANALYZER FOUND NO ADDITIONAL ISSUES INVOLVING THE POWER SUPPLY. A COMPLAINT QUERY IDENTIFIED THE CURRENT COMPLAINT AND ONE ADDITIONAL COMPLAINT, WHICH WAS OPENED ON (B)(6) 2009 REGARDING THE EQUIPMENT TURNING OFF ON ITS OWN. WHEN TURNING THE SYSTEM BACK ON A BURNING ODOR WAS NOTICED, BUT THERE WAS NO VISIBLE SMOKE. THE CPU WOULD NOT RESPOND. FIELD SERVICE INSTALLED A NEW CPU SOURCE (POWER SUPPLY) TO RESOLVE THE ISSUE. THE COMPLAINT REVIEW DOES NOT SUPPORT AN ADVERSE TREND RELATED TO THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-105) (B)(6), 2008, PROVIDED INFORMATION TO ADDRESS THE CURRENT ISSUE AT THIS CUSTOMER SITE. THE C8000 IS CERTIFIED TO THE APPROPRIATE (B)(6) AND INTERNATIONAL SAFETY STANDARDS TO ENSURE THAT THE DESIGN PROVIDES ADEQUATE PROTECTION AGAINST SPREAD OF FIRE FROM THE EQUIPMENT. A MALFUNCTION OF THE POWER SUPPLY WITHIN SCC (B)(4) WAS IDENTIFIED. THE POWER SUPPLE WAS REPLACED TO RESTORE OPERATION. BASED ON THE INVESTIGATION FINDINGS, A SPECIFIC CAUSE WAS NOT IDENTIFIED AND THERE IS NO INDICATION OF A DEFICIENCY OF THE ARCHITECT C8000 SYSTEM. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT SHE HEARD A "POP" FROM THE ARCHITECT C8000 ANALYZER'S SYSTEM CONTROL CENTER'S (SCC) CENTRAL PROCESSING UNIT (CPU). THIS WAS FOLLOWED BY AN ELECTRICAL SMELL AND SMOKE. NO SPARKS OR FIRE WERE PRESENT. THE ANALYZER WAS IN "READY" STATUS BUT NO SAMPLES WERE BEING PROCESSED AT THE TIME. THE CUSTOMER UNPLUGGED THE CPU AND A SERVICE CALL WAS INITIATED. THE CUSTOMER VERIFIED THAT NO INJURIES OCCURRED DUE TO THIS ISSUE. THERE ARE NO REPORTS OF ANY DAMAGE TO THE SURROUNDING ENVIRONMENT. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH SCC CPU LN: 7D01-03