BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THYMATRON DGX

    MDR report key: 332834 · Received May 7, 2001

    Report

    Report Number
    332834
    Event Type
    Injury
    Date Received
    May 7, 2001
    Date of Event
    April 27, 2001
    Report Date
    May 4, 2001
    Manufacturer
    SOMATICS INC
    Product Code
    GXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PREPARED FOR 3RD ECT TREATMENT. PHYSICIAN APPLIED THYMAPADS AT TEMPLES. CERTIFIED REGISTERED NURSE ANESTHETIST ADMINISTERED SEDATION AND WAS VENTILATING PT WITH MAPLESOR BAG AND O2. AS PHYSICIAN ADMINISTERED THE ECT STIMULUS, A FLASH OF FIRE ERUPTED ACROSS THE PT'S RIGHT CHEEK, RESULTING IN MOSTLY 1ST AND 2ND DEGREE BURNS. THE PHYSICIAN EXTINGUISHED THE FLAME IMMEDIATELY AND PROVIDED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20774 THYMATRON DGX ECT MACHINE GXC SOMATICS INC NA NA
    20775 THYMAPAD ELECTRODES GXC SOMATICS INC NA 376707J0

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R