BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROJACK FOR BMSI/NICOLETONE LTM

    MDR report key: 874834 · Received June 29, 2007

    Report

    Report Number
    2126317-2007-00001
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    May 3, 2007
    Report Date
    June 18, 2007
    Manufacturer
    VIASYS NEUROCARE INC.
    Product Code
    GWQ
    PMA / PMN Number
    K891405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK ASSESSMENT PERFORMED INDICATES THAT THE MISWIRING OF THE MICROJACK PT INTERFACE MAY LEAD TO MISDIAGNOSIS. INVESTIGATION HAS PROGRESSED AS TO THE CAUSE, EFFECT AND CORRECTIVE ACTION. A DEFECT HAS BEEN FOUND TO HAVE BEEN CAUSED BY MISASSEMBLED PRINTED CIRCUIT BOARD ASSEMBLY. STOCK AND IN PROCESS MATERIALS HAVE BEEN CHECKED AND VERIFIED TO BE CORRECT. PROCESSES HAVE BEEN IMPLEMENTED TO INSURE THAT THIS MANUFACTURING ERROR IS TESTED FOR, AS A SEPARATE VERIFICATION STEP IN ALL FUTURE MANUFACTURING. CUSTOMERS SHIPPED PRODUCT DURING THE TIME OF DEC. 13, 2003 TO MAY 2007 WILL BE NOTIFIED AND PROVIDED WITH TESTING INSTRUCTIONS. AFFECTED PRODUCT WILL BE REMOVED FROM USE AND REPLACE. ONLY A VERY SMALL PERCENTAGE OF MICROJACKS ARE EXPECTED TO BE AFFECTED.

    Description of Event or Problem · 1

    DURING DEPTH ELECTRODE EEG STUDY OF A PT IN PREPARATION FOR BRAIN SURGERY, THE USER OBSERVED WHAT WAS PERCEIVED AS NON-LOGICAL DATA OUTPUT. FURTHER INVESTIGATION INDICATED THAT THE MICROJACK BOX WAS FOUND TO BE MISWIRED. THERE WAS NO INJURY TO THE PT REPORTED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROJACK FOR BMSI/NICOLETONE LTM EEG SYSTEM GWQ VIASYS NEUROCARE INC. MICROJACK BMSI/LTM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other