BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS 2CH COMBO

    MDR report key: 1082278 · Received July 25, 2008

    Report

    Report Number
    1022819-2008-00186
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF DEVICE: IMG, GZJ, HCC, GZI. CHATTANOOGA GROUP TOOK ACTION WITH THE CLIENT TO CONFIRM THAT THE DEVICE HAD RECEIVED THE FIELD CORRECTION. THE CLIENT BIOMEDICAL DEPT STAFF HAD COMPLETED THE SOFTWARE INSTALL AND APPLICABLE CHATTANOOGA GROUP FORMS. THE CLIENT FAXED IN THE APPLICABLE FORMS TO CHATTANOOGA GROUP TO INDICATE THE FIELD CORRECTION HAD BEEN COMPLETED. CHATTANOOGA GROUP UPDATED THE FIELD CORRECTION FILES TO INDICATE THAT THE DEVICE HAD BEEN UPDATED.

    Description of Event or Problem · 1

    FDA RECALL FIELD CORRECTION EFFECTIVENESS CHECK. THE FDA CONDUCTED ROUTINE EFFECTIVENESS INSPECTIONS OF THE DEVICES TO INSURE THAT THE DEVICE HAD BEEN UPDATED WITH THE SOFTWARE ISSUED OF THE RECENT RECALL FIELD CORRECTION. THE FDA DEEMED THAT THE DEVICES HAD NOT BEEN UPDATED. THE POTENTIAL FOR PT SKIN BURN AND/OR SHOCK EXIST, DUE TO THE RECALL/FIELD CORRECTION SOFTWARE NOT BEING INSTALLED. THIS POTENTIAL ADVERSE EVENT AND/OR PRODUCT PROBLEM COULD RESULT IN A PT INJURY. NO INJURY/ADVERSE EVENT OCCURRED TO A PT. CHATTANOOGA GROUP WAS NOTIFIED OF THE FDA FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO IPF CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability