BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 23193092 · Received October 1, 2025

    Report

    Report Number
    1220908-2025-03634
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    June 22, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    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 DEVICE WAS RETURNED TO ZOLL UK FOR EVALUATION. THE REPORTED ECG MONITORING FAILURE COULD NOT BE REPLICATED. LOG REVIEW SHOWED ECG MONITORING FAILURE COINCIDING WITH AN INTERMITTENT CONNECTION OF THE MULTIFUNCTION (MFC) CABLE TO THE DEVICE. WE DID VARIOUS TESTS WITH THE RETURNED MFC CABLE AND CPRD CONNECTOR CONFIRMED, AND THE DEVICE FUNCTIONED PROPERLY. THE MFC RECEPTACLE, MFC CABLE, AND CPRD CONNECTOR WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF 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 MONITORING FAILURE" MESSAGE. 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
    2216714 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221111-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown