BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 1180209 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00262
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    November 15, 2007
    Report Date
    November 15, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: NO PAD SENT WITH UNIT, LEADS WERE INTERMITTENT WITH SEVERAL END THAT COULD BE PULLED OFF. FULL FUNCTIONAL CHECK WAS CONDUCTED ON ALL WAVEFORMS ON ALL FOUR CHANNELS AND THE UNIT PERFORMED TO SPECIFICATIONS. SYSTEM CONTROL BOARD SOFTWARE REVISION IS 3.1. MUSCLE STIMULATOR BOARD SOFTWARE REVISION IS 2.1. ULTRASOUND BOARD REVISION SOFTWARE IS 2.1. AS A SECONDARY MEANS OF EVALUATING THE DEVICE, THE ENGINEERING TECHNICIAN CONDUCTED A TREATMENT ON HIS ARM. THE UNIT WAS FOUND TO BE WORKING CORRECTLY, NO SHOCKING OR BURNING PADS. RECOMMENDING RETURNING TO SERVICE DEPARTMENT FOR GENERAL PRODUCT UPDATES AND TO RETURN TO SERVICE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE PT WAS BURNED DURING AN ELECTROTHERAPY TREATMENT. THE ANATOMICAL LOCATION OF THE BURN IS UNK. THE BURN WAS IN THE AREA OF THE ELECTRODE. CLINICIAN DOES NOT HAVE ALL OF THE PADS TO RETURN FOR EVAL. NO REPORTED INJURY TREATMENT AND/OR POST INJURY TREATMENT WAS REPORTED FROM THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG IPF, IMG, GZJ, GZI IPF CHATTANOOGA GROUP 2788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention