BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 22819422 · Received August 15, 2025

    Report

    Report Number
    1220908-2025-03000
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 25, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE REPORTED COMPLAINT OF MULTI-FUNCTION CABLE (MFC) PADS NOT RECOGNIZED WAS CONFIRMED IN THE LOGS BUT COULD NOT BE DUPLICATED DURING TESTING. LOG REVIEW SHOWED MULTIPLE CABLE ID CHANGES, SUGGESTING AN INTERMITTENT CONNECTION WITH THE MFC. THE MFC USED DURING THE EVENT WAS NOT RETURNED FOR EVALUATION. THE DEVICE PASSED FUNCTIONAL TESTING INCLUDING UNDER VIBRATION WITHOUT DUPLICATING THE REPORT. THE DEFIB RECEPTABLE WAS REPLACED AS A PRECAUTION AND A NEW MFC WAS RETURNED WITH THE DEVICE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. 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
    1301315 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2221011-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown