BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21976799 · Received May 7, 2025

    Report

    Report Number
    1220908-2025-01559
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019143
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE FUNCTIONED CORRECTLY AND AS DESIGNED. THE REPORTED ECG NO SIGNAL ISSUE ON APRIL 16, 2025, WAS INVESTIGATED. PADS WERE USED, AND AN ECG SIGNAL WAS DISPLAYED SUCCESSFULLY, FOLLOWED BY A SHOCK DELIVERY. NO ISSUES WITH SIGNAL ACQUISITION OR CABLE FUNCTION WERE FOUND. THE DEVICE AND MULTIFUNCTION CABLE PASSED ALL TESTS. THE DEVICE FUNCTIONS AS INTENDED AND 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 MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. 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
    1820583 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2221011-01 NA 00847946019143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown