BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 23629898 · Received November 24, 2025

    Report

    Report Number
    1220908-2025-04390
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE BATTERY. THE CUSTOMER WAS ADVISED TO SCRAPPED THE BATTERY USED DURING THE EVENT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) (REV: G) SPEAKS TO THE CRITICALITY OF HAVING A BACK-UP POWER SOURCE WHEN USING THE DEVICE AND INSTRUCTS THE USER 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". ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307104 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2421511-13 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown