BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES

    MDR report key: 22069966 · Received May 22, 2025

    Report

    Report Number
    1220908-2025-01980
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 16, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PRO-PADZ ELECTRODES, R SERIES DEVICE, AND MULTIFUNCTION CABLE (MFC) WERE RETURNED TO ZOLL MEDICAL UNITED KINGDOM FOR EVALUATION. VISUAL INSPECTION SHOWED DISCOLORATION ON THE PADS SUGGESTING A DISCHARGE, BUT NO SIGNS OF BURNING OR ARCING. ALL COMPONENTS WORKED CORRECTLY WITH NO CONNECTION ISSUES. DEVICE LOGS CONFIRMED CARDIOVERSIONS OCCURRED ON 5/14/2025, BUT ACTIVITY LOGS WERE UNAVAILABLE, MAKING IMPEDANCE VERIFICATION INCONCLUSIVE. PHOTOS SUBMITTED BY THE CUSTOMER SHOWED REDDENING ON THE SKIN IN PAD-SHAPED PATTERNS. THE ANTERIOR PAD MARK APPEARED AS HYPEREMIA WHILE THE POSTERIOR PAD SHOWED A DEEPER BURN-LIKE MARK, LIKELY RELATED TO HIGH PATIENT IMPEDANCE. CONTRIBUTING FACTORS MAY INCLUDE POOR ELECTRODE COUPLING, INADEQUATE SKIN PREPARATION, OR INCORRECT PAD PLACEMENT. THE INSTRUCTION FOR USE (IFU) SPECIFIES CORRECT PAD PLACEMENT, AND DEVIATION FROM THIS COULD CONTRIBUTE TO POOR COUPLING. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A 68-YEAR-OLD FEMALE PATIENT; AFTER REMOVING THE ELECTRODE PADS, A SECOND-DEGREE BURN WAS FOUND ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060728 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001000301110053 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other