BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 24629733 · Received March 18, 2026

    Report

    Report Number
    1220908-2026-00907
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 24, 2026
    Report Date
    February 27, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. LOGS WERE REVIEWED AND FOUND EVIDENCE OF ECG MONITORING FAILURE IN CONJUNCTION WITH RAPID CABLE ID CHANGES DURING THE SAME EVENT. THE FINDINGS ARE CONSISTENT WITH AN INTERMITTENT OR COMPROMISED MULTIFUNCTION CABLE (MFC), WHICH MAY HAVE CAUSED OSCILLATION BETWEEN THE MFC PINS AND DEVICE RECEPTACLE RESULTING IN FRETTING OBSERVED DURING EVALUATION. THE CUSTOMER'S MFC WAS NOT RETURNED FOR EVALUATION. NO UNSUPPORTED ID CABLE, CABLE FAULT, OR RESET EVENTS WERE IDENTIFIED IN THE LOGS. BENCH TESTING AND ECG STRESSING PERFORMED ON THE RETURNED DEVICE DID NOT DUPLICATE THE REPORTED ISSUE OR IDENTIFY A DEVICE MALFUNCTION. AS A PRECAUTION, THE MFC RECEPTACLE WAS REPLACED AND A NEW MFC WILL BE PROVIDED TO THE CUSTOMER. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. 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
    347382 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2221011-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown