BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 23451453 · Received November 3, 2025

    Report

    Report Number
    1220908-2025-04063
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017538
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. DURING DISASSEMBLY OF THE DEVICE TO DETERMINE ROOT CAUSE, THE TECHNICIAN OBSERVED DAMAGE NOT CONSISTENT WITH TYPICAL USE. THE RETURNED POWER CORD SHOWED CARBON BUILDUP, AND THE PADS PACKAGING APPEARED TO HAVE BURN MARKS. THIS TYPE OF DAMAGE LIKELY RESULTED FROM USER INVOLVEMENT, SUCH AS THE CORD BEING PLUGGED INTO A LIVE WALL OUTLET WHILE THE PADS PACKAGE MADE CONTACT WITH THE POWER CORD CONTACTS WHILE PLUGGED IN, CAUSING BURNING AND DAMAGE TO THE PADS PACKAGING. THE POWER CORD AND PADS WERE SCRAPPED. THE DEVICE ITSELF SHOWED NO DAMAGE AND WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, AN ARC WAS HEARD FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078053 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001005201310013 NA 00847946017538

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown