BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 22954554 · Received September 3, 2025

    Report

    Report Number
    1220908-2025-03261
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA FOR EVALUATION. THE REPORTED ISSUE OF ECG MONITORING FAILURE COULD NOT BE REPLICATED DURING EVALUATION. LOG REVIEW SHOWED ECG MONITORING EVENTS OCCURRING SIMULTANEOUSLY WITH RAPID MULTIFUNCTION CABLE (MFC) ID CHANGES, INDICATING THAT THE MULTIFUNCTION CABLE CONNECTION TO THE DEVICE WAS A FACTOR. THE DEVICE PASSED ALL FUNCTIONAL TESTING USING THE RETURNED MFC CABLE. THE MFC RECEPTACLE AND MFC CABLE WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331750 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2221011-06 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown