BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 21808124 · Received April 9, 2025

    Report

    Report Number
    1220908-2025-01204
    Event Type
    Death
    Date Received
    April 9, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE COULDN'T CONSISTENTLY RECOGNIZED A VALID CABLE ID, WHICH PREVENTED ENERGY DELIVERY AND CPR FEEDBACK. THIS SUGGESTS A POOR CONNECTION BETWEEN THE MULTIFUNCTION CABLE (MFC) AND THE DEVICE. THE MFC, MFC RECEPTACLE, AND CPRD ADAPTOR WERE REPLACED AS A PRECAUTION. 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 DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO CHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460001 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-01 NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death