BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24578600 · Received March 12, 2026

    Report

    Report Number
    1220908-2026-00830
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    February 20, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946030919
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE REPORTED EVENT OF DEVICE POWERING OFF UNEXPECTEDLY COULD NOT BE DUPLICATED DURING EVALUATION. REVIEW OF THE DEVICE LOG CONFIRMED THE DEVICE WAS OPERATING ON BATTERY POWER AND ISSUED A BATTERY RECALIBRATION MESSAGE, FOLLOWED APPROXIMATELY 11 MINUTES LATER BY A LOW BATTERY AND SHUTDOWN WARNING. THE BATTERY WILL BE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) (REV: G) INSTRUCTS USERS TO ALWAYS CARRY AT LEAST ONE FULLY CHARGED SPARE BATTERY. IF NO OTHER SOURCE OF BACK-UP POWER IS AVAILABLE, TWO SPARE BATTERIES ARE ADVISABLE TO PREVENT POWER-RELATED ISSUES. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    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 TREAT A 67-YEAR-OLD FEMALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN WAS ABLE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122326 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2421211-01 NA 00847946030919

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female