BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADPRO

    MDR report key: 23862775 · Received December 22, 2025

    Report

    Report Number
    23862775
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 3, 2025
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    UDI-DI
    10653405042488
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER ANESTHESIA PROVIDED SEDATION; 200 J OF SYNCHRONIZED ENERGY USED, AND A SMALL POP OCCURRED AT THE SITE OF THE PAD. SO, WE CHANGED THE PADS AND REPEATED THE CARDIOVERSION WITH 200 J AND PRESSURE, AND PATIENT CONVERTED TO SINUS RHYTHM. THE PADS WERE REMOVED THERE DOES NOT APPEAR TO BE ANY BURN MARKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874755 PADPRO AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ CONMED CORPORATION 2001Z-C Y04252501 10653405042488

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male