BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 23571222 · Received November 17, 2025

    Report

    Report Number
    1220908-2025-04348
    Event Type
    Death
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946005979
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER REPORTED THAT THE PADS COULD NOT BE ATTACHED DURING AN EVENT BECAUSE THE CPR ADAPTER WOULD NOT FULLY CONNECT TO THE MULTIFUNCTION CABLE (MFC). PHOTOS PROVIDED BY THE CUSTOMER SHOWED THAT THE CABLE CONNECTOR WAS DAMAGED, PREVENTING THE CPR ADAPTER FROM SEATING AND RESULTING IN A DELAY WHILE ALTERNATIVE ACCESSORIES WERE OBTAINED. THE EXACT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER WAS ADVISED THAT WHILE CPR ADAPTER IS REQUIRED FOR CPR FEEDBACK, THERAPY CAN STILL BE DELIVERED BY CONNECTING THE PADS DIRECTLY TO THE MFC. ANALYSIS OF 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODES PADS WOULD NOT CONNECT TO THE MULTI-FUNCTION CABLE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. HOWEVER, IT WAS NOT ATTRIBUTED TO THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296195 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2221011-01 NA 00847946005979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death