BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THYMATRON

    MDR report key: 1131323 · Received August 6, 2008

    Report

    Report Number
    1131323
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    SOMATICS, LLC
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ELECTROCONVULSIVE THERAPY MACHINE CONTINUED TO GENERATE CURRENT TO THE PATIENT THROUGH PATCHES PLACED ON THE PATIENT'S TEMPORAL AREA AFTER THE PHYSICIAN STOPPED THE TREATMENT. THE NURSE ATTEMPTED TO REMOVE THE PATCHES AND RECEIVED A SHOCK. THE MACHINE WAS IMMEDIATELY TURNED OFF AND THE PATCHES WERE REMOVED. THE PATIENT WAS OBSERVED IN PACU, TRANSFERRED TO A NURSING UNIT FOR ROUTINE OBSERVATION, AND DISCHARGED HOME THAT DAY.

    Description of Event or Problem · 1

    THE ELECTROCONVULSIVE THERAPY MACHINE CONTINUED TO GENERATE CURRENT TO THE PATIENT THROUGH PATCHES PLACED ON THE PATIENT'S TEMPORAL AREA AFTER THE PHYSICIAN STOPPED THE TREATMENT. THE NURSE ATTEMPTED TO REMOVE THE PATCHES AND RECEIVED A SHOCK. THE MACHINE WAS IMMEDIATELY TURNED OFF AND THE PATCHES WERE REMOVED. THE PATIENT WAS OBSERVED IN PACU, TRANSFERRED TO A NURSING UNIT FOR ROUTINE OBSERVATION, AND DISCHARGED HOME THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYMATRON ECT MACHINE GWQ SOMATICS, LLC SYSTEM IV *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR