BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE 2 CH STIM

    MDR report key: 1180912 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00224
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    April 24, 2007
    Report Date
    April 24, 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
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY.

    Description of Event or Problem · 1

    DEVICE SHOCKED PT DURING ELECTROTHERAPY TREATMENT. 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 MOBILE 2 CH STIM IPF, GZJ, GZI IPF CHATTANOOGA GROUP 2777

    Patients

    Seq Age Sex Outcome Treatment
    1