BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 5032411 · Received August 21, 2015

    Report

    Report Number
    1220908-2015-02173
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE EVENT ELECTRODES WERE RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE ELECTRODES FOUND AN EXCESSIVE AMOUNT OF HAIR ATTACHED TO THE ADHESIVE FOAM. ZOLL RECOMMENDS THAT PATIENTS ARE CLEANED AND CLIPPED PRIOR TO APPLYING ELECTRODE PADS TO ASSURE GOOD COUPLING OF ELECTRODE TO SKIN CONTACT. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING AND OPERATED TO SPECIFICATION. THIS INVESTIGATION WAS CLOSED AS IMPROPER PATIENT PREPARATION PRIOR TO THE APPLICATION OF THE ELECTRODES. ANALYSIS FOR 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 FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR AN (B)(6), MALE PATIENT THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEFIBRILLATOR TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, IN THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555962 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death