BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24277193 · Received February 6, 2026

    Report

    Report Number
    1220908-2026-00283
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 18, 2026
    Report Date
    January 19, 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 ON 01/18/2026 AT 08:51:42, THE DEVICE RECORDED AN "UNKNOWN SINGLE CABLE ID" AND CABLE FAULT UPON POWER UP WHILE IN AED MODE. DURING THE EVENT, TWO ANALYSIS CYCLES WERE INTERRUPTED BY "DEFIB LEAD FAULT" AND "CHECK PADS" MESSAGES, CONSISTENT WITH A DISRUPTION IN ECG DETECTION POTENTIALLY RELATED TO THE MALFUNCTION CABLE (MFC), MFC RECEPTACLE, OR PATIENT INTERFACE. INSPECTION OF THE RETURNED MFC SHOWED EVIDENCE OF FRETTING. FUNCTIONAL TESTING WITH A KNOWN-GOOD MFC DID NOT REPRODUCE THE ISSUE, AND THE DEVICE SUBSEQUENTLY PASSED FULL FUNCTIONAL TESTING AND OPERATED AS INTENDED. THE MFC AND MFC RECEPATCLE WAS 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 63-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO ANALYZE. 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
    337896 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2321011-26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male