BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 21266725 · Received January 29, 2025

    Report

    Report Number
    1220908-2025-00273
    Event Type
    Death
    Date Received
    January 29, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 8, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND MULTIFUNCTION CABLE (MFC) WERE RETURNED TO ZOLL MEDICAL CORPORATION; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE RETURNED MFC CABLE WAS FOUND TO HAVE GASKET MATERIAL INSIDE THE MFC CABLE CONNECTOR CAUSING INTERFERENCE WITH DEVICE CONNECTION. 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

    THIS DEVICE WAS MANUFACTURED BEFORE THE UDI REQUIREMENTS. 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 WHILE ATTEMPTING TO MONITOR AN 81-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER THEY DO NOT BELIEVE IT WAS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515399 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2221011-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death