BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENIX

    MDR report key: 24840905 · Received April 10, 2026

    Report

    Report Number
    1220908-2026-01161
    Event Type
    Death
    Date Received
    April 10, 2026
    Date of Event
    March 15, 2026
    Report Date
    March 17, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00198843000100
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE USER REPORTED THAT THE DEVICE WAS UNABLE TO ACQUIRE AN ECG SIGNAL. DURING EVALUATION, THE ISSUE COULD NOT BE REPRODUCED. THE DEVICE AND MULTIFUNCTION CABLE PASSED ALL FUNCTIONAL, ECG, AND SIMULATOR TESTING WITH NO ABNORMALITIES IDENTIFIED. REVIEW OF THE DEVICE LOGS SHOWED NO INDICATION THAT PADS WERE PROPERLY CONNECTED TO THE PATIENT; A BRIEF ECG SIGNAL WAS DETECTED, FOLLOWED BY LEAD FAULT MESSAGES INDICATING LOSS OF CONNECTION. BASED ON THESE FINDINGS, THE EVENT IS MOST LIKELY ATTRIBUTED TO POOR ACCESSORY CONNECTION OR INADEQUATE ELECTRODE CONTACT WITH THE PATIENT. 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 WAS UNABLE TO ACQUIRE AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620111 ZENIX AUTOMATED EXTERNAL DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1116-321B4B-11-USA-0 NA 00198843000100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death