BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24187596 · Received January 27, 2026

    Report

    Report Number
    1220908-2026-00163
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 7, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS. ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. DEVICE LOGS FOR THE REPORTED EVENT SHOWED INTERMITTENT ?NOISY? ECG SIGNALS AND MULTIPLE "PADS OFF" MESSAGES, WITH TRANSIENT LOSS OF SIGNAL. HIGH IMPEDENCE WAS NOTED, WHICH IS LIKELY DUE TO POOR ELECTRODE-TO-SKIN COUPLING. WHEN ELECTRODE CONTACT IMPROVED, THE ECG SIGNAL WAS REGAINED AND THE DEVICE SUCCESSFULLY DELIVERED TWO SHOCKS. TESTING OF THE RETURNED DEVICE AND ACCESSORIES COULD NOT REPRODUCE THE ISSUE. BASED ON LOG REVIEW AND EVALUATION, NO DEVICE MALFUNCTION WAS IDENTIFIED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 29 YEAR OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253142 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male