BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24839426 · Received April 10, 2026

    Report

    Report Number
    1220908-2026-01203
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019761
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH TESTING AND ECG STRESSING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. REVIEW OF THE DEVICE LOGS IDENTIFIED ECG MONITORING FAILURE OCCURRING IN CONJUNCTION WITH RAPID CABLE ID CHANGES DURING THE SAME EVENT. THESE ENTRIES ARE LIKELY RELATED AND SUGGEST THE MULTI-FUNCTION CABLE (MFC) GASKET MAY BE MISSING OR COMPROMISED, OR THAT THE MFC IS INTERMITTENTLY FUNCTIONAL. THE MFC WAS NOT RETURNED FOR EVALUATION. THE MFC RECEPTACLE WAS REPLACED AS A PRECAUTION. 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 DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537140 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2261511-01 NA 00847946019761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown