BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 3002811 · Received March 13, 2013

    Report

    Report Number
    1628664-2013-00056
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT LABELING REVIEW FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL CONTAIN ADEQUATE INFORMATION FOR THE DESCRIBED ISSUE. A HISTORICAL/QUALITY DATA REVIEW DID NOT IDENTIFY ANY ADVERSE TREND OF A PRESSURE MONITOR SENSOR ASSEMBLY ISSUE. A SERVICE HISTORY REVIEW FOUND NO SERVICE HISTORY ISSUES FOR C16000 SERIAL NO. (B)(4). NO ADDITIONAL COMPLAINTS FOR PRESSURE MONITOR SENSOR ASSEMBLY ISSUES, OR FOR SMOKING ISSUES WERE FOUND TO HAVE BEEN DOCUMENTED FOR C16000 SERIAL NO. (B)(4) SINCE THE FSR SERVICED THE ANALYZER AND REPLACED THE DAMAGED/BURNED PRESSURE MONITOR SENSOR ASSEMBLY. A REVIEW FOUND THE SAFETY HAZARDS MEMO CONTAINS ADEQUATE INFORMATION NOTING ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST SPREAD OF FIRE FROM THE EQUIPMENT. THE COMPLAINT INVESTIGATION INFORMATION DID NOT REASONABLY SUGGEST A PRESSURE MONITOR SENSOR ASSEMBLY DEVICE MALFUNCTION CAUSED THIS ISSUE. NO SYSTEMIC DEFICIENCY OR ADVERSE TREND OF A PRESSURE MONITOR SENSOR ASSEMBLY ISSUE WAS IDENTIFIED DURING INVESTIGATION. THE DEVICE IS MEETING PERFORMANCE SPECIFICATIONS AND PERFORMING AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SMOKE COMING FROM THE ARCHITECT C16000 ANALYZER, SERIAL NUMBER (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER SITE AND COULD SMELL A BURNING ODOR. THE FSR IDENTIFIED THAT LIQUID HAD LEAKED ONTO THE PRESSURE MONITOR SENSOR ASSEMBLY, AND THE PRESSURE MONITOR SENSOR ASSEMBLY HAD BEEN DAMAGED/BURNED DUE TO THE LEAKING LIQUID. THE FSR REPLACED THE DAMAGED/BURNED PRESSURE MONITOR SENSOR ASSEMBLY. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105510 ARCHITECT C16000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1