BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 23285078 · Received October 15, 2025

    Report

    Report Number
    1220908-2025-03788
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 29, 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

    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 MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE MFC CABLE WAS RECEIVED AND EVALUATED. IT WAS VERIFIED DURING TESTING THAT THE PIN A1 OF MFC HAD AN OPEN CIRCUIT. MFC WAS SCRAPPED. NO EMERGING TREND BASED ON SIMILAR REPORTS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL UNITED KINGDOM FOR EVALUATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTTED THE MULTIFUNCTION CABLE (MFC). THE MFC WAS SCRAPPED AFTER TESTING. 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 MONITORING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. 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
    2482762 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221111-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown