BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 16358294 · Received February 10, 2023

    Report

    Report Number
    1220908-2023-00355
    Event Type
    Death
    Date Received
    February 10, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 12, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946029715
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT OF A DEFIB CHARGE TIMEOUT WAS OBSERVED DURING REVIEW OF THE DEVICE HISTORY LOGS. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING DEFIB CYCLING TEST WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE BATTERY, MULTIFUNCTION CABLE AND MFC ADAPTER USED DURING THE EVENT WERE RETURNED FOR EVALUATION; NO DISCREPANCIES WERE FOUND DURING TESTING. THE BATTERY WAS SCRAPPED AS A PRECAUTION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 64-YEAR-OLD FEMALE PATIENT, THE DEVICE DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE. 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
    58099 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946029715

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death