BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24802327 · Received April 7, 2026

    Report

    Report Number
    1220908-2026-01220
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019259
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ECG MONITORING FAILURE COULD NOT BE REPLICATED DURING EVALUATION. HOWEVER, DEVICE LOGS CAPTURED AN ECG MONITORING FAILURE EVENT COINCIDING WITH RAPID MULTI-FUNCTION CABLE (MFC) ID CHANGES, SUGGESTING AN INTERMITTENT CONNECTION LIKELY DUE TO A COMPROMISED OR MISSING MFC GASKET. THE DEVICE SUCCESSFULLY PASSED ALL FUNCTIONAL TESTING, AND NO FAULTS WERE IDENTIFIED DURING EVALUATION. THE MFC CABLE WAS NOT RETURNED FOR EVALUATION. BASED ON AVAILABLE EVIDENCE, THE ISSUE IS ATTRIBUTED TO A SUSPECTED INTERMITTENT MFC CABLE CONDITION. DISCARDING AND REPLACING THE ASSOCIATED MFC CABLE IS RECOMMENDED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. 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
    866965 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2231011-01 NA 00847946019259

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown