BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE COMBO

    MDR report key: 1180915 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00229
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 8, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY.

    Description of Event or Problem · 1

    DEVICE WAS REPORTED TO BE SHOCKING PT DURING INTERFERENTIAL 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 COMBO IPF, IMG, GZJ, GZI IPF CHATTANOOGA GROUP 2778

    Patients

    Seq Age Sex Outcome Treatment
    1