BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 21335816 · Received February 7, 2025

    Report

    Report Number
    1220908-2025-00413
    Event Type
    Death
    Date Received
    February 7, 2025
    Date of Event
    January 15, 2025
    Report Date
    January 17, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    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

    THIS DEVICE WAS MANUFACTURED BEFORE THE UDI REQUIREMENTS. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. A REVIEW OF DEVICE LOGS FOUND THE DEVICE PROMPTED DEFIB CABLE ID "MULTIFUNCTION-PADS" MESSAGE. NO ECG SIGNAL WAS DETECTED FOR THREE MINUTES DESPITE MULTIPLE TROUBLESHOOTING ATTEMPTS, INCLUDING POWER CYCLING AND RECONNECTING THE MULTIFUNCTION CABLE (MFC). THE OPERATOR WAS ABLE TO OBTAIN AN ECG SIGNAL IN LEAD II VIEW BUT ENCOUNTERED A PADS LEAD FAULT WITH NO SIGNAL WHEN SWITCHING BACK TO PADS VIEW. THE DEVICE PASSED ALL FUNCTIONAL TESTING WITH TEST PADS AND MFC CABLE. THE CUSTOMER'S ACCESSORIES WERE NOT RETURNED FOR EVALUATION. THE CUSTOMER IS ADVISED TO ASSESS THEIR ACCESSORIES FOR COMPATIBILITY AND FUNCTIONALITY. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 71-YEAR-OLD FEMALE PATIENT, THE FIRST EMS CREW ATTACHED THEIR PADS TO THIS DEVICE AND THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THE CLINICIAN OBTAINED A NEW SET OF PADS TO CONTINUE TREATING THE PATIENT BUT THE DEVICE WAS STILL UNABLE TO OBTAIN AN ECG SIGNAL VIA PADS. THE CREW UTILIZED A 4-LEAD PLACEMENT TO MONITOR THE PATIENT'S HEART RHYTHM FOR THE REMAINDER OF THE CALL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125039 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2231011-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death