BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIO CLEAR

    MDR report key: 15551194 · Received October 6, 2022

    Report

    Report Number
    MW5112463
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 5, 2022
    Manufacturer
    CARDIO MEDICAL PRODUCTS, INC.
    Product Code
    LDD
    UDI-DI
    00814907020265
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CARDIOVERSION PROCEDURE, WHEN PHYSICIAN PRESSED BUTTON TO DEFIB PATIENT, THE DEFIB CARDIO CLEAR PAD IGNITED IN FLAMES WHICH CAUGHT SURROUNDING BEDDING AND OXYGEN MASK TO ALSO IGNITE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799976 CARDIO CLEAR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD CARDIO MEDICAL PRODUCTS, INC. Z100 Y042822-04 00814907020265

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other