BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA 360

    MDR report key: 92736 · Received August 2, 1994

    Report

    Report Number
    92736
    Event Type
    Malfunction
    Date Received
    August 2, 1994
    Date of Event
    January 31, 1994
    Report Date
    February 18, 1994
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    GYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A 2ND/3RD DEGREE NICKEL SIZE BURN ABOVE THE RIGHT TEMPLE AFTER ELCECTROCONVULSIVE THERAPY. THE ELECTRODES WERE NOT MAKING GOOD ELECTRICAL CONTACT WITH THE PT. NURSING BELIEVES THAT THE HEADBAND WAS TOO LOOSE. THE STIMULATOR PASSED THE SELF-TEST PRIOR TO USE. GEL USED. IS NOT RECOMMENDED FOR ECT. STIMULATOR PASSED ALL PERFORMANCE TESTS TO MFR'S SPECIFICATIONS. EXPERIMENTAL TESTING VERIFIED THAT STIMULATOR CAN PASS SELF-TEST BUT STILL CAUSE A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA 360 ELECTRODE GEL GYB PARKER LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ECT STIMULATOR| MECTA MODEL SR, SN2366,