BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATION ELECTRODES

    MDR report key: 24858469 · Received April 13, 2026

    Report

    Report Number
    24858469
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 10, 2026
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WITH CARDIOVERSION WAS PERFORMED ON A PATIENT. THE TEE PORTION OF THE PROCEDURE WAS COMPLETED AND TEE PROBE REMOVED. THE PATIENT WAS RECEIVING SUPPLEMENTAL OXYGEN (O2) TO PATIENT WITH AN O2 FACE MASK. CARDIOVERSION AT 200 JOULES WAS PERFORMED. AT THIS POINT, A SPARK WAS NOTED IN THE AREA OF THE DEFIBRILLATOR PADS. AFTER THE CARDIOVERSION, A YELLOW/ORANGE GLOW WAS NOTED WITH RAPID DEVELOPMENT OF A FLAME EMANATING FROM THE PATIENT'S CHEST AND NECK AREA. THE SONOGRAPHER HEARD A POP DURING THE CARDIOVERSION AND SAW A FLASH FOLLOWED BY FLAMES COMING OUT OF THE MASK. THE LINENS THEN CAUGHT ON FIRE. OXYGEN WAS IMMEDIATELY REMOVED BY THE ANESTHESIOLOGIST. THE SONOGRAPHER PUT THE FIRE OUT WITH A TOWEL. WATER WAS POURED ONTO THE CHEST AND NECK REGION. THE PATIENT WAS ASSESSED WITH 2ND DEGREE BURNS NOTED ON THE CHEST AND NECK. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOLLOWED BY A TRANSFER TO A BURN CENTER FOR EVALUATION AND TREATMENT OF THE BURNS. THIS INCLUDED ADMISSION TO THE BURN UNIT AND A SURGICAL PREPARATION FOLLOWED BY AN APPLICATION OF SKIN SUBSTITUTE TO THE NECK AND CHEST. THE PATIENT WAS NOT NOTED TO HAVE ANY OTHER INJURY THAN THE 2ND DEGREE BURNS TO THE CHEST AND NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917762 DEFIBRILLATION ELECTRODES PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) DRO TZ MEDICAL, INC. P-211-Z1 Y082525-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| S| O| R| L