BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS 4CH COMBO

    MDR report key: 1161196 · Received September 15, 2008

    Report

    Report Number
    1022819-2008-00267
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.

    Description of Event or Problem · 1

    CLINICIAN WAS USING THE DEVICE TO TREAT TWO PTS AT THE SAME TIME. BOTH PTS WERE BEING TREATED WITH THE 'PRE-MOD' WAVEFORM. THE 1X1 INCH ELECTRODES WERE BEING USED ON BOTH PTS. THE ELECTRODES WERE NOT RETURNED FOR EVAL. THE PTS HAVE NO KNOWN PRE-EXISTING CONDITIONS. THE PTS HAD RECEIVED ELECTROTHERAPY TREATMENT PRIOR TO THIS EVENT. PATIENT A WAS LYING ON STOMACH AND HAD TWO ELECTRODES PLACED ON THE LOWER BACK. CHANNEL 1 WAS USED TO TREAT THIS PT. THE INTENSITY WAS INCREASED UNTIL THE PT FELT TINGLING AND THE TREATMENT STARTED. NO PREP OF THE AREA OF PLACEMENT WAS DONE. AFTER PT A'S TREATMENT WAS STARTED, ELECTRODES WERE PLACED ON BOTH SIDES OF THE ELBOW OF PT B. BEFORE THE TREATMENT WAS STARTED, SHE STARTED YELLING GET THEM OFF, GET THEM OFF AND STATED THAT SHE WAS BEING SHOCKED. PT A COMPLAINED THAT THE INTENSITY CONTINUED TO INCREASE AND 1 MINUTE INTO THE TREATMENT, THE TREATMENT WAS ENDED AND THE ELECTRODES REMOVED. THIS CLINICIAN NOTED THAT THIS UNIT WAS INVOLVED IN A RECALL AND HAD BEEN UPDATED.

    Additional Manufacturer Narrative · 2

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVALUATION. THE DEVICE EVALUATION AND ANY ADD'L FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 2

    CLINICIAN WAS USING THE DEVICE TO TREAT TWO PTS AT THE SAME TIME. BOTH PTS WAS BEING TREATED WITH THE 'PRE-MOD' WAVEFORM. THE 1X1 INCH ELECTRODES WAS BEING USED ON BOTH PTS. THE ELECTRODES WAS NOT RETURNED FOR EVAL. THE PTS HAVE NO KNOWN PRE-EXISTING CONDITIONS. THE PTS HAD RECEIVED ELECTROTHERAPY TREATMENT PRIOR TO THIS EVENT. PATIENT A WAS LYING ON STOMACH HAD TWO ELECTRODES PLACED ON THE LOWER BACK. CHANNEL 1 WAS USED TO TREAT THIS PT. THE INTENSITY WAS INCREASED UNTIL THE PT FELT TINGLING AND THE TREATMENT STARTED. NO PREP OF THE AREA OF THE PLACEMENT WAS DONE. AFTER PT A'S TREATMENT WAS STARTED, ELECTRODES WERE PLACE ON BOTH SIDES OF THE ELBOW OF PT B. BEFORE THE TREATMENT WAS STARTED, SHE STARTED YELLING GET THEM OFF, GET THEM OFF AND STATED THAT SHE WAS BEING SHOCKED. PT A COMPLAINED THAT THE INTENSITY CONTINUED TO INCREASE AND 1 MINUTE INTO THE TREATMENT, THE TREATMENT WAS ENDED AND THE ELECTRODES REMOVED. THIS CLINICIAN NOTED THAT THIS UNIT WAS INVOLVED IN A RECALL AND HAD BEEN UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 4CH COMBO IMG; GZI, GZJ, HCC, IPF, LIH IMG CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention
    2 70 YR Required Intervention