BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT ADVANCED 2CH

    MDR report key: 1180933 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00236
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    May 16, 2007
    Report Date
    May 16, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY.

    Description of Event or Problem · 1

    DEVICE WAS REPORTED TO HAVE SHOCKED A PATIENT. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PATIENT OUTPUT FROM THE INTENDED OUTPUT TO AN UNINTENDED HIGHER VOLTAGE OUTPUT. WHEN SUCH A MALFUNCTION OCCURS, IT RESULTS IN A SHOCK SENSATION AND POSSIBLE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT ADVANCED 2CH IPF, IMG, GZJ, HCC, GZI IPF CHATTANOOGA GROUP 2762CC

    Patients

    Seq Age Sex Outcome Treatment
    1