BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24505415 · Received March 4, 2026

    Report

    Report Number
    1220908-2026-00633
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Report Date
    February 12, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946018757
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION THE REPORT WAS OBSERVED AND ATTRIBUTED TO A SYSTEM INTERCONNECTION FLEX CABLE THAT WAS NOT FULLY SEATED TO A CONNECTOR ON THE PROCESSOR/BRIDGE/PACE BOARD. THE FLEX CABLE WAS REPLACED TO RESOLVE THE REPORT. IT COULD NOT BE FIRMLY ESTABLISHED HOW THE FLEX CABLE BECAME LOOSE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO EMERGING TREND BASED ON SIMILAR REPORTS.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST FOR DEFIB AND PACER FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52049 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-0221511-01 NA 00847946018757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown