BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24403120 · Received February 20, 2026

    Report

    Report Number
    1220908-2026-00477
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 2, 2026
    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

    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 CANADA FOR EVALUATION. DEVICE LOGS WERE REVIEWED AND SHOWED EVIDENCE OF AN ECG MONITORING FAILURE OCCURRING WITH RAPID DEFIBRILLATION CABLE ID CHANGES AND A CABLE FAULT WITHIN THE SAME EVENT. THESE LOG ENTRIES SUGGEST THE ISSUES WAS LIKELY RELATED TO THE MULTIFUNCTION CABLE (MFC), POSSIBLY DUE TO A MISSING OR COMPROMISED GASKET OR AN INTERMITTENT MFC CONNECTION CAUSING OSCILLATION BETWEEN THE MFC PINS AND THE DEVICE RECEPTABLE. THE CUSTOMER'S MFC WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH TESTING AND ECG STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE MFC RECEPATCLE WAS REPLACED AS A PRECAUTION. THE CUSTOMER WAS ADVISED TO DISCARD THE MFC USED DURING THE EVENT. 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 WHILE ATTEMPTING TO MONITOR 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
    463006 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2321011-26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown