BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24641233 · Received March 19, 2026

    Report

    Report Number
    1220908-2026-00843
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 24, 2026
    Report Date
    February 25, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946029678
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER REPORT COULD NOT BE DUPLICATED DURING TESTING WITH A KNOWN GOOD BATTERY. THE BATTERY USED DURING THE EVENT WAS NOT RETURNED FOR EVALUATION. DEVICE LOG REVIEW CONFIRMED THE REPORT AND INDICATED THE BATTERY REQUIRED CALIBRATION, WHICH MAY RESULT IN INACCURATE RUNTIME INDICATION AND USER ADVISORY ALERTS FOR LOW BATTERY. THE DEVICE PASSED ALL TESTING SUCCESSFULLY. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) (REV: G) INSTRUCTS 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 PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE 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
    698029 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2431112-01 NA 00847946029678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown