BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 17672427 · Received September 1, 2023

    Report

    Report Number
    1220908-2023-03485
    Event Type
    Death
    Date Received
    September 1, 2023
    Date of Event
    August 22, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO A FAULTY MFC-TO-CPRD CONNECTOR. THE CPR ADAPTOR WAS DISCARDED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. IT'S NOTEWORTHY TO MENTION THAT THE CUSTOMER RESOLVED THE ISSUE DURING THE EVENT AND WAS ABLE TO ADMINISTER 7 SHOCKS TO THE PATIENT. THE DAMAGE TO THE ADAPTOR PREVENTED AN ADEQUATE CONNECTION, PREVENTING THE PROPER ID OF THE SIGNAL. SINCE THE ID WAS NOT RECOGNIZED, THE DEVICE PREVENTED AN ANALYSIS. RECONNECTING THE CPR ADAPTOR CORRECTED THE OBSERVATION. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO ANALYZE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986771 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death