BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE COMBO

    MDR report key: 1182051 · Received September 22, 2008

    Report

    Report Number
    1022819-2008-00237
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    May 22, 2007
    Report Date
    May 22, 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

    A CUSTOMER WAS GIVING TREATMENT TO ONE OF HIS PT'S AND THE PT RECEIVED A SHOCK. THE TREATMENT PARAMETERS ARE AS FOLLOWS: STIM: CHANNEL 1. IFC - 2POLE. SWEEP - ON. BEAT LOW - 80HZ. CYCLE TIME 4/12. CC/CV - CC. FREQ - 250HZ. INTENSITY - 0.1MA. 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 TO THE AREA BENEATH THE ELECTRODE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT MOBILE COMBO IPF, IMG, GZJ, HCC, GZI IPF CHATTANOOGA GROUP 2778

    Patients

    Seq Age Sex Outcome Treatment
    1