BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT XT 2CH COMBO PKG

    MDR report key: 2247676 · Received September 8, 2011

    Report

    Report Number
    9616086-2011-00099
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 10, 2011
    Report Date
    September 9, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNIT BURNED PATIENTS. THE DEVICE EVALUATION REPORT INDICATED THAT NO DAMAGE WAS FOUND THE UNIT AND LEAD CHANNELS ARE IN LIKE NEW CONDITION. ESTIM TREATMENTS ARE EXACT REPLICATIONS OF THE DESIRED SIGNALS. THE LEAD WIRES IMPEDANCE MEASURED TO SPECIFICATIONS, CONNECTIONS WERE NOT INTERMITTENT OR OPEN. POWER LEVEL OUTPUT WAS WITHIN TOLERANCES. NO ERRORS OCCURRED DURING TREATMENT. HI-POT AND LEAKAGE CURRENT PASS ELECTRICAL SAFETY TESTING. LEAKAGE CURRENT AND GROUND CONTINUITY HAVE MET SPECIFICATION REQUIREMENTS. THE UNIT PASSED INSPECTION. THE WAVEFORMS APPEARED AS NORMAL, AND THE UNIT MAINTAINED NORMAL FUNCTIONALITY. NO PROBABLE CAUSE OF AN INCIDENT COULD BE DUPLICATED AND THE UNIT PASSES QC INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT XT 2CH COMBO PKG ELECTROTHERAPY GZJ DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other