BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES

    MDR report key: 24138887 · Received January 21, 2026

    Report

    Report Number
    1220908-2026-00145
    Event Type
    Death
    Date Received
    January 21, 2026
    Date of Event
    December 24, 2025
    Report Date
    January 2, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017163
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL FOR EVALUATION WITH ASSOCIATED ACCESSORIES. A REVIEW OF DEVICE LOGS FOR THE REPORTED EVENT (B)(6) 2025 CONFIRMED THE DEVICE WAS OPERATIONAL AND DELIVERED SIX SHOCKS BETWEEN 13:01:12 AND 13:09:10. PRIOR TO THE FIRST THREE SHOCKS, REPEATED "CHECK PADS" AND "POOR PAD CONTACT" MESSAGES WERE RECORDED, WITH A 15-20 OHM IMPEDANCE DISPARITY INDICATING POOR COUPLING. AFTER PAD INTERVENTION/REPLACEMENT, THE SUBSEQUENT THREE SHOCKS SHOWED NORMAL IMPEDANCE WITH NO DISPARITY. CUSTOMER-PROVIDED IMAGES SHOWED PAD PLACEMENT OVER A SKIN FOLD, LIKELY CONTRIBUTING TO POOR COUPLING AND RESULTING IN A BURN. EVALUATION OF RETURNED ACCESSORIES FOUND THEM TO FUNCTIONING AS EXPECTED. THE MULTIFUNCTION CABLE (MFC) PATIENT SIDE WAS SLIGHTLY CRACKED AND CONFIRMED TO BE FUNCTIONAL. THE MFC WILL BE REPLACED AS A PRECAUTION. THE DEVICE PASSED ALL FUNCTIONAL AND BENCH TESTING. THE REPORTED POPPING SOUND IN THE CUSTOMER REPORT IS CONSISTENT WITH AIR ENTRAPMENT DUE TO PAD ADHESION AND PLACEMENT. THE IFU REINFORCES THE IMPORTANCE OF ELECTRODE PREPARATION AND PLACEMENT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 54-YEAR-OLD FEMALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN CAUSING REDDENING AND BURNS ON THE PATIENT. THE DEVICE WOULD RESTART AFTER AN ATTEMPT TO DISCHARGE AND A LOUD POP NOISE WAS HEARD AFTER DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400713 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001000001110012 NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death