BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 4960920 · Received July 28, 2015

    Report

    Report Number
    1220908-2015-01997
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4) AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE CUSTOMER REPORT. THE EVENT DATA FILE WAS RETURNED TO ZOLL HEADQUARTERS AND EVALUATED. EVALUATION OF THE CLINICAL DATA CONFIRMS THE USER POWERED THE DEVICE ON IN PACER MODE, APPLIED THE ELECTRODES TO THE PATIENT, AND ATTEMPTED TO SWITCH TO PADS VIEW. BY DESIGN, THE DEVICE WILL NOT SWITCH TO PADS VIEW WHILE IN PACER MODE. THE CLINICAL DATA SHOWS THE DEVICE BEING POWERED DOWN FOLLOWED BY THE DEVICE BEING POWERED ON AND SWITCHED TO LEAD II AS THE VIEWING LEAD., NOT PADS. THE FILE ALSO TELLS US THAT THERE WAS A VIABLE PATIENT IMPEDANCE IN PADS AND LEAD II WAS IN A LEAD FAULT CONDITION. OUR CONCLUSION IS THE DEVICE WORKED AS DESIGNED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT WITH VITAL SIGNS ABSENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT ALLEGED THE CLINICIAN REPLACED THE ELECTRODE PADS, CHECKED CABLE CONNECTIONS, AND RESTARTED THE DEVICE TO NO AVAIL. COMPLAINANT ALLEGED THEY CONTINUED TREATMENT BY SWITCHING TO THE FIRE DEPARTMENT'S SAED DEVICE AND ELECTRODE PADS WHILE MONITORING IN 12 LEAD WITH THIS AED DEVICE. THE SAED DEVICE DELIVERED TWO SHOCKS TO THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488289 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death