BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES

    MDR report key: 23747570 · Received December 8, 2025

    Report

    Report Number
    1220908-2025-04571
    Event Type
    Death
    Date Received
    December 8, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017309
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL AND WAS EVALUATED ALONG WITH THE MFC CABLE FROM THE ALLEGED EVENT. THE DEVICE LOG WAS REVIEWED AND DOES NOT SUGGEST ANY ATTEMPTS BY THE USER TO CHARGE OR USE THE DEVICE ON THE DATE OF TEH EVENT. THE CUSTOMER CONFIRMED THIS WAS THE CORRECT DEVICE THAT WAS RETURNED. THE DEVICE PASSED ALL TESTING SUCCESSFULLY. 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 FAILED TO 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
    2774928 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001001001130013 NA 00847946017309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death