BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2823151 · Received November 7, 2012

    Report

    Report Number
    1628664-2012-00471
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED BY THE FIELD SERVICE ENGINEER (FSE) ADJUSTING THE COUNTERBALANCE WEIGHT ON THE HINGES OF THE COVER LID. THE FSE VERIFIED THE LID REMAINED OPENED AND DID NOT FALL AGAIN, AND INDICATED THAT THE INSTRUMENT IS PERFORMING AS INTENDED. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, PERFORMING A ONE YEAR COMPLAINT SEARCH, AND REVIEWING THE INSTRUMENT SERVICE HISTORY. THE ONE YEAR COMPLAINT SEARCH DID NOT RETURN ANY OTHER COMPLAINTS REGARDING THE COVER LID FALLING AND CAUSING INJURY AND THE SERVICE HISTORY OF THE INSTRUMENT DID NOT RETURN ANY COMPLAINTS REGARDING THE COVER LID AS WELL. THE ARCHITECT C16000 SERVICE MANUAL INDICATES THAT THE TOP AND REAR COVER LIDS ARE CHECKED FOR PROPER OPERATION DURING PREVENTIVE MAINTENANCE BY THE FSE. BASED ON THE RESULTS OF THIS EVALUATION, IT WAS DETERMINED THAT A DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THE OPERATOR STATED THE UPPER FRONT PROCESSING COVER OF THE ARCHITECT C16000 FELL DOWN AND HIT THE OPERATOR ON THE HEAD. THERE WAS NO INJURY OR DAMAGE TO THE OPERATOR'S HEAD. THE OPERATOR ADJUSTED THE TENSION OF THE ARCHITECT C16000 RETENSION SPRING. NO PATIENT INVOLVEMENT. NO INJURY TO THE OPERATOR'S HEAD WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1