BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT ADVANCED STIM MONOCHROME

    MDR report key: 1180211 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00226
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    March 20, 2007
    Report Date
    March 20, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY. DEVICE 2: BRAND NAME: VACUUM MODULE W/CART PKG. DEVICE NAME: VACUUM ELECTRODE MODULE. MODEL #: 2774, CATALOG #: 2774, SERIAL #: (B)(4).

    Description of Event or Problem · 1

    UNIT SHOCKED STAFF MEMBER OF HEALTH FACILITY AFTER INSTALLATION OF THE DEVICE. RESULTED IN BURN. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PT 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 STIM MONOCHROME IPF, GZJ, GZI IPF CHATTANOOGA GROUP 2773MS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention