BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 22115146 · Received May 30, 2025

    Report

    Report Number
    1220908-2025-02041
    Event Type
    Death
    Date Received
    May 30, 2025
    Date of Event
    May 16, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CANADA EVALUATED THE DEVICE AND MULTIFUNCTION CABLE (MFC) AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING USING THE RETURNED MFC, A KNOWN GOOD ROC ADAPTOR, AND PADS WITHOUT DUPLICATING THE REPORT. THE MFC CONNECTOR WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE LOG SHOWED AT THE START OF THE EVENT, THE OPERATOR HAD ATTACHED CPR PADS TO THE DEVICE. THE DEVICE PROMPTED ATTACH PADS REPEATEDLY WITH NO ECG SIGNAL DISPLAYED, INDICATING THAT IT DID NOT DETECT A VALID PATIENT IMPEDANCE. THE LOG DID NOT RECORD ANY PATIENT IMPEDANCE, CPR WAVEFORM, OR FEEDBACK FROM CPR PADS DURING THIS TIME. THIS IS NORMAL BEHAVIOR IF THE DEVICE IS NOT ABLE TO DETECT A VALID PATIENT IMPEDANCE AT ANY POINT. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. 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 THAT WHILE ATTEMPTING TO DEFIBRILLATE A 77-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PATIENT; HOWEVER, THE SAME ISSUE ENSUED. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844103 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2321011-26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death