BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA GENISYS 2CH COMBO

    MDR report key: 1180930 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00239
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    May 25, 2007
    Report Date
    May 25, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    MUSCLE STIMULATOR SHOCKED PATIENT. THERAPIST SET UP AT INTENSITY OF 20 AND THE PATIENT SAID THAT IT WAS TO STRONG BACKED OFF TO 10 AND IT WAS STILL TO STRONG. SHE LOOKED AT THE ELECTRODE AND IT HAD TURNED BLACK. SHE WENT TO SET UP CHRONIC PAIN PROTOCOL AND BEFORE SHE DID ANYTHING WITH TE INTENSITY, IT SHOCKED PATIENT, THERAPIST PUT IT ON HERSELF AND IT DID THE SAME THING. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PATIENT 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 TO THE AREA BENEATH THE ELECTRODE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO IPF, IMG, GZJ, HCC, GZI IPF CHATTANOOGA GROUP 2761

    Patients

    Seq Age Sex Outcome Treatment
    1