BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 8147657 · Received December 10, 2018

    Report

    Report Number
    1220908-2018-03547
    Event Type
    Death
    Date Received
    December 10, 2018
    Date of Event
    November 18, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946004330
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE'S ACTIVITY LOG WAS RETURNED TO ZOLL MEDICAL CORPORATION; REVIEW OF THE DEVICE LOG CONFIRMS THE END USER HAD GOOD CONTACT AND A SIGNAL DISPLAYED WITH THE ONE-STEP ELECTRODES. ONCE SWITCHED TO PACER MODE, WHICH MUST BE VIEWED THROUGH ECG MONITORING LEADS, THE SIGNAL WAS LOST. WE CAN CONFIRM THAT THE ECG LEADS ARE ATTACHED TO THE DEVICE, BUT CANNOT CONFIRM IF THEY WERE ATTACHED TO THE PATIENT. THERE ARE MANY FACTORS THAT MAY LEAD TO HAVING NO ECG SIGNAL DISPLAYED, ELECTRODES NEVER BEING ATTACHED TO THE PATIENT, DAMAGED/DEFECTIVE ECG CABLE, POOR PATIENT PREP, AND POOR COUPLING EVEN THOUGH ON-DEMAND PACING REQUIRES A HIGH QUALITY ECG SIGNAL, IT IS IMPORTANT TO NOTE THAT THE DEVICE WAS CAPABLE OF "FIXED" PACING (DEVICE BYPASSES ECG SIGNAL AND PROVIDES CONSISTENT PACER PULSES) HAD THE ATTEMPT BEEN MADE. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) PATIENT (GENDER UNKNOWN) IN CRITICAL ARREST, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988275 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA 00847946004330

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death