BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUUM ELECTRODE MODULE

    MDR report key: 2244699 · Received September 18, 2008

    Report

    Report Number
    1022819-2008-00274
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE FOR EXPORT ONLY MODELS 2785 AND 2762CC. DEVICE NOT AVAILABLE FOR EVAL. THE CUSTOMER DOES NOT WANT TO RETURN THE DEVICE FOR EVAL. UNABLE TO PERFORM EVAL ON THE DEVICE. SINCE THE DEVICE WAS NOT RETURNED FOR EVAL, NO ROOT CAUSE CAN BE DETERMINED. DEVICE B: BRAND NAME: INTELECT ADVANCED 2CH COLOR COMBO; COMMON DEVICE NAME: IPF, IMG, GZJ, HCC, GZI; MFR NAME, CITY AND STATE: CHATTANOOGA GROUP, (B)(4); MODEL#: 2762CC; CATALOG#: 2762CC; SERIAL#: (B)(4).

    Description of Event or Problem · 1

    PT RECEIVED A SKIN BURN DURING AN ELECTROTHERAPY TREATMENT. THE PT WAS BEING TREATED IN THE AREA OF THE BACK OF THE THORACIC AND LUMBAR AREA ALONG THE PARASPINAL AREA. THE PT DID NOT COMPLAINT OF ANY PAIN OR DISCOMFORT DURING THE TREATMENT. BUT AFTER THE TREATMENT THE CLINICIAN NOTED REDNESS AND THE PRONATION OF BLISTERING. FOR THE TREATMENT THE VACUUM ELECTRODE MODULE WAS BEING USED TO APPLY THE ELECTRODES. THE CLINICIAN NOTED THAT THE SUCTION POWER OF VACUUM ELECTRODE MODULE IS TOO WEAK TO APPLY TO THE BACK OF THE NECK. THE CLINICIAN NOTED THAT NO BURNS OCCUR WHEN USING SELF ADHESIVE ELECTRODES. THE CLINICIAN WAS USING THE INTERFERENTIAL WAVEFORM. THE TREATMENT TIME WAS 20 MINUTES. THE INTENSITY WAS SET TO 20 - 30 MA USING CHANNEL 1 AND 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUUM ELECTRODE MODULE VACUUM ELECTRODE IMG CHATTANOOGA GROUP 2785

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention