BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD 3700 SL

    MDR report key: 854374 · Received May 23, 2007

    Report

    Report Number
    2919069-2007-00067
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    April 12, 2007
    Report Date
    April 12, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K991605
    Removal / Correction Number
    2919069-5/16/07-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. CELL-DYN 3000CS, 510 (K): K955673. CELL-DYN 3000SL, 510(K): K955673. CELL-DYN 3500CS, 510(K) : K955715. CELL-DYN 3500SL, 510(K) : K955715. CELL-DYN 3700CS, 510(K): K991605. CELL-DYN 3700SL, 510(K) : K991605.

    Description of Event or Problem · 1

    CD 3700 ELECTRO-MAGNETIC COMPATIBILITY (EMC) TESTING FAILED ELECTRO STATIC DISCHARGE (ESD) TEST. THE FLOW CONTROL MODULE (FCM) BOARD WAS DAMAGED AS A RESULT OF ESD DISCHARGED AT 4KV ON THE LEVEL-SENSOR CONNECTORS OF THE REAGENT RESERVOIR ON THE LEFT SIDE OF THE INSTRUMENT. THIS WAS FOUND DURING PERFORMANCE OF THE ANNUAL TESTING OF THE INSTRUMENT AND IS DUE TO THE EXPOSED LEVEL SENSOR CONNECTOR NEAR THE POWER SWITCH IN THE REAGENT RESERVOIR. THIS ISSUE COULD ALSO AFFECT TH ANALYZERS, WHICH ALSO HAVE EXPOSED CONNECTORS. IN THE FAILURE MODE, AN ELECTROSTATIC DISCHARGE TO THE LEVEL SENSE CONNECTOR COULD LEAD TO INSTRUMENT FAILURE AND INABILITY TO RUN STAT HEMOGLOBIN SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3700 SL AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR