BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO MULTI MODALITY SYSTEM

    MDR report key: 474187 · Received July 24, 2003

    Report

    Report Number
    MW1029109
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    February 28, 2003
    Report Date
    July 24, 2003
    Manufacturer
    NICOLET BIOMEDICAL INC.
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY LOST APPROX. 110 PT EEG WAVERFORMS. THE ARCHIVING FUNCTION FAILED AFTER PT'S EEG WERE RECORDED, THE DR. READ AND MADE HIS REPORT. PT DATA IS SUPPOSED TO BE ARCHIVED ON RECORDABLE CDS. THE FILES APPEARED TO TRANSFER TO THE CD. AFTER ARCHIVING, THE FILES HAD THE CORRECT NAME AND FILE SIZE. HOWEVER, THE FILES COULD NOT BE REOPENED FOR REVIEW.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/25/03: THE NEUROCARE GROUP OF VIASYS HEALTHCARE INC, FORMERLY NICOLET BIOMEDICAL INC EVALUATED A COMPLAINT WITH REGARD TO THE INABILITY TO RECOVER ARCHIVED PT EEG WAVEFORMS FROM A BRAVO EEG SYSTEM. AFTERT INVESTIGATION OF THE COMPLAINT, CO HAS MADE THE FOLLOWING CONCLUSIONS: THE COMPLAINT IS ATTRIBUTABLE TO THE CD READER/WRITER COMPONENT SET UP OF THE COMPLAINANT'S BRAVO MEDICAL DEVICE. IN FEBRUARY CO RECEIVED INDICATION OF TWO NON RECOVERABLE ACHIEVED DATA FILES ON A BRAVO MEDICAL DEVICE. TO CORRECT THIS DATA ACHIEVE RECOVERY PROBLEM THE SETUP OF THE CD WRITER WAS ADJUSTED. THIS ISSUE WAS CORRECTED WITH THE COMPLAINANT ON MARCH 7TH, 2003 AND THE TWO REPORTED NON-READABLE ACHIEVE FILES WERE RECOVERED. MFR HAS NO OTHER BRAVO DEVICE CUSTOMERS THAT HAVE COMMUNICATED THIS PROBLEM TO NICOLET BIOMEDICAL. THE MEDWATCH REPORT WAS MFR'S FIRST INDICATION OF BRAVO DEVICE ADD'L ACHIEVED DATA FILES THAT COULD NOT BE OPENED. THE READABILITY OF THE ARCHIEVED EEG DATA FILES MAY BE RECOVERED BY APPLICATION OF A SOFTWARE RECOVERY TOOL. MFR IS WORKING WITH THE COMPLAINANT TO RECOVER THE CD ARCHIEVED DATA FILES. MFR AGREES WITH THE VOLUNTARY MEDWATCH REPORTER THAT THIS IS NOT AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO MULTI MODALITY SYSTEM ELECTROENCEPHLOGRAPH GWQ NICOLET BIOMEDICAL INC. BRAVO EEG *

    Patients

    Seq Age Sex Outcome Treatment
    1 *