BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 10853658 · Received November 17, 2020

    Report

    Report Number
    1220908-2020-03608
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019259
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. REVIEW OF THE DATA FILE FROM THE EVENT SHOWED THAT PADS WERE ATTACHED AND A SIGNAL WAS PRESENT IN LEAD VIEW. THE DEVICE WAS SWITCHED TO PACER MODE AND BY DESIGN, LEAD VIEW WAS SWITCHED TO LEAD II. PAD LEAD VIEW IS NOT A VISIBLE LEAD WHILE IN PACER MODE. THE USER CHANGED LEADS MULTIPLE TIMES, BUT NEVER ATTACHED ECG LEADS OR PRESSED A DEFIB RELATED BUTTON. THE DEVICE REMAINED IN PACER MODE. THE DEVICE MET SPECIFICATIONS AND PERFORMED AS DESIGNED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT, AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6)-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319149 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946019259

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death