BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 21867439 · Received April 18, 2025

    Report

    Report Number
    1220908-2025-01476
    Event Type
    Death
    Date Received
    April 18, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. HOWEVER, THE DEVICE LOGS WERE PROVIDED FOR REVIEW. REVIEW OF THE DEVICE LOGS SHOW THAT THE USER RECEIVED A PADS ON MESSAGE AT 2:45:23 WITH A CLEAR ECG SIGNAL. AT APPROXIMATELY 3:01:00, THE SIGNAL BECAME NOISY AND UNSTABLE. BY 3:04:15, REPEATED PADS OFF MESSAGES BEGAN, AND THE ECG SIGNAL WAS LOST FOR APPROXIMATELY 4 MINUTES. AT 3:10:15, A PADS ON MESSAGE AND CLEAR ECG SIGNAL RETURNED, LIKELY AFTER THE PADS WERE REPLACED. THE ISSUE APPEARS TO BE DUE TO POOR ELECTRODE TO PATIENT CONTACT (POOR COUPLING). CONTRIBUTING FACTORS COULD BE ELECTRODE PAD PLACEMENT, SKIN PREOPERATION, OR ASSOCIATED WITH PATIENT'S CLINICAL CONDITION (EXAMPLE: DIAPHORETIC). ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. 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 MONITOR A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE CREW SUBSEQUENTLY CHANGED THE PADS FOR A NEW SET AND WERE ABLE TO OBTAIN A RHYTHM ON THE SCREEN WITH THE REPLACEMENT PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31326 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221712-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death