BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21785623 · Received April 7, 2025

    Report

    Report Number
    1220908-2025-01106
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DATA FILE FROM THE EVENT DATE WAS PROVIDED. A REVIEW OF THE DEVICE LOG INDICATES THE CUSTOMER WAS NOT IN THE CORRECT MODE OF OPERATION (USER ACTIVATED PACE). THE DEVICE WAS POWERED ON IN MANUAL MODE WHERE THE ECG SIGNAL WAS SEEN IN PADS VIEW. THE USER THEN TURNED THE DEVICE TO PACER MODE FOR THE REMAINDER OF THE CASE. ACCORDING TO THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01, REV: G): "WHEN THE DEVICE IS IN PACE MODE, THE LEAD SELECTION IS RESTRICTED TO LEADS I, II, OR III.". THE CUSTOMER WAS INFORMED THAT THE DEVICE WAS OPERATING AS INTENDED AND COULD BE RETURNED TO NORMAL SERVICE. THE HOSPITAL'S CLINICAL EDUCATOR WAS CONTACTED FOR TRAINING. 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 MONITOR A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE CLINICIAN REPLACED THE DEVICE TO CONTINUE TO TREAT THE PATIENT. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731870 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-0221511-06 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown