BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELECTLECT TRANSPORT ULTRASOUND

    MDR report key: 1027648 · Received April 10, 2008

    Report

    Report Number
    1022819-2008-00115
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID EXCEED +20 % OUTPUT SETTING IN THE UPPER OUTPUT RANGE. HOWEVER, EXCEEDING THIS THRESHOLD WILL NOT LIKELY RESULT IN A SHOCK SENSATION OR BURNING EFFECT.

    Description of Event or Problem · 1

    THE PATIENT WAS PRESCRIBED ULTRASOUND THERAPY FOR LOWER BACK PAIN DUE TO MUSCLE TIGHTNESS. THE CLINICIAN HAD THE ULTRASOUND TREATMENT PARAMETERS SET TO OUTPUT 1 WATT PER CENTIMETER SQUARE AT A CONTINUOUS DUTY CYCLE. THE OUTPUT FREQUENCY WAS SET TO 1 MHZ. THE TREATMENT TIME WAS TO BE 8 MINUTES. THE CLINICIAN WAS TO APPLY THE TREATMENT WITH A 10 CENTIMETER SQUARE SURFACE AREA ULTRASOUND APPLICATION. THE CLINICIAN APPLIED THE COUPLING GEL TO THE TREATMENT AREA. THE CLINICIAN PROCEEDED TO START AND APPLY ULTRASOUND APPLICATION WHEN THE PATIENT IMMEDIATELY COMPLAINED OF A SHOCKING SENSATION BEING EMITTED FROM THE ULTRASOUND APPLICATOR. THE CLINICIAN IMMEDIATELY STOPPED THE TREATMENT. THE PATIENT WAS NOT INJURED AS A RESULT OF THE MALFUNCTION. THE CLINICIAN CHANGED THE APPLICATOR AND CONNECTED A 5 CENTIMETER SQUARED APPLICATOR TO THE SOURCE DEVICE. THE CLINICIAN RESTARTED THE TREATMENT AND EXPERIENCED THE SAME SHOCKING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECTLECT TRANSPORT ULTRASOUND IMG, STIMULATOR, ULTRASOUND AND MUSCLE, IMG CHATTANOOGA GROUP 2782

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other