BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 5466505 · Received February 29, 2016

    Report

    Report Number
    1220908-2016-00467
    Event Type
    Death
    Date Received
    February 29, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL WITH THE EVENT ELECTRODE PADS. BASED ON THE AVAILABLE EVIDENCE IT DOES NOT APPEAR THAT THE REPORTED EVENT WAS RELATED TO A DEVICE MALFUNCTION. INSTEAD THE ISSUE MAY HAVE BEEN RELATED TO ELECTRODE APPLICATION OR POOR CONTACT BETWEEN ELECTRODES AND PATIENT SKIN. THIS IS CONFIRMED BY THE PRESENCE OF HAIR, BLOOD, AND SCALY SKIN ON THE ELECTRODES. A REVIEW OF THE CLINICAL DATA SHOWED ATTEMPTS TO TROUBLESHOOT, CHANGING THE PADS AND THE MFC. THERE WAS NO INDICATION THAT AN ATTEMPT TO DISCHARGE ENERGY WAS MADE AT ANY TIME. THE CUSTOMER'S REPORT THAT THE DEVICE WAS UNABLE TO DISCHARGE WAS NOT CONFIRMED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. PLEASE REFERENCE MEDWATCH REPORT 1220908-2016-00468 FOR THE FIRST DEVICE IN THE PATIENT EVENT. 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 MEDICS RESPONDED TO A SCENE, UPON AN ATTEMPT TO DEFIBRILLATE THE PATIENT (AGE & GENDER UNKNOWN) THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2016-00468 FOR THE 1ST DEVICE IN THIS PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123245 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death