BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 11807441 · Received May 11, 2021

    Report

    Report Number
    1220908-2021-01591
    Event Type
    Death
    Date Received
    May 11, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019778
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE CUSTOMER'S REPORT WAS NOT OBSERVED DURING EVALUATION. REVIEW OF THE DEVICE LOGS CONFIRMS THE DEVICE WAS USED ON (B)(6) 2021 UNTIL THE BATTERY WAS FULLY DEPLETED AND SHUTDOWN WITH A LOW BATTERY AND DEVICE SHUTDOWN WARNING. THE DEVICE REMAINS IN THIS STATE UNTIL AUXILIARY POWER IS APPLIED ON (B)(6) 2021. THIS CONFIRMS THAT THERE WAS NO DEVICE MALFUNCTION, AND THE DEVICE OPERATED AS DESIGNED IN THE PRESENCE OF A DEPLETED BATTERY. THE ZOLL OPERATOR'S GUIDE (9650-002355-01) STATES TO CHECK BATTERIES DURING DAILY SHIFT CHECKS AND TO CARRY A FULLY CHARGED SPARE AT ALL TIMES. 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702346 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946019778

    Patients

    Seq Age Sex Outcome Treatment
    1 Death