BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATION ELECTRODES

    MDR report key: 13051706 · Received December 21, 2021

    Report

    Report Number
    13051706
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 11, 2021
    Report Date
    December 13, 2021
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS CARDIOVERTED THREE TIMES IN THE EMERGENCY ROOM. AFTER PROCEDURE WAS DONE AND PADS WERE REMOVED. BURNS WERE PRESENT ON THE CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950126 DEFIBRILLATION ELECTRODES PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) DRO TZ MEDICAL, INC. P-211-Z1 Y100821-11

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA Female Other