BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 11164976 · Received January 13, 2021

    Report

    Report Number
    1220908-2021-00106
    Event Type
    Death
    Date Received
    January 13, 2021
    Report Date
    January 5, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL UNITED KINGDOM EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING, ECG MONITORING STRESS TESTING, AND ANALYZING FUNCTIONAL STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS INDICATED THAT A PATIENT IMPEDANCE IS NEVER RECOGNIZED. ELECTRODES ARE RECOGNIZED AS ATTACHED TO THE DEVICE, BUT NOT TO A PATIENT. THERE ARE MANY REASONS WHY THE DEVICE MAY NOT HAVE DETECTED A VALID PATIENT IMPEDANCE, INCLUDING BUT NOT LIMITED TO: PADS NOT APPLIED TO PATIENT PADS ARE NOT FULLY INSERTED INTO THE MFC (OR CPR-D ADAPTER) PROPER CONNECTION BETWEEN PADS AND ADAPTER FAULTY CPR-D ADAPTER/MFC ON THE PATIENT END FAULTY PADS PREVENTING PROPER CONNECTION FAULTY PADS PREVENTING IDENTIFICATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND. THE PADS USED AT THE TIME OF THE REPORTED EVENT WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN) IN CARDIAC ARREST, THE DEVICE DID NOT RECOGNIZE THAT IT WAS ATTACHED TO A PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58044 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death