BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 18958288 · Received March 22, 2024

    Report

    Report Number
    1220908-2024-01090
    Event Type
    Death
    Date Received
    March 22, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 4, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019259
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE AND MULTIFUNCTION CABLE (MFC) WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE DEFIB PADS USED DURING THE EVENT WERE NOT RETURNED FOR EVALUATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING USING THE CUSTOMER'S RETURNED MFC WITHOUT DUPLICATING THE REPORT. REVIEW OF THE DEVICE LOG SHOWS A LARGE DIFFERENCE BETWEEN THE MEASURED IMPEDANCES WHICH IS EVIDENCE OF POOR COUPLING BETWEEN THE PATIENT AND THE ELECTRODES BEING USED. THE FIRST DISCHARGE HAD A DISCHARGE IMPEDANCE OF 106 OHMS AND DELIVERED 256.3 JOULES. THE SECOND DISCHARGE HAD A DISCHARGE IMPEDANCE OF 217 OHMS AND DELIVERED 304 JOULES. THIS SECOND SHOCK RESULTED IN THE CUSTOMER'S REPORT OF THE PAD SPARKING. DESPITE THE SHOCK, THE DISCHARGE APPEARED TO HAVE BEEN SUCCESSFUL WHICH WAS FURTHER CONFIRMED THROUGH COMMUNICATION WITH THE CUSTOMER. IT WAS CONFIRMED THAT THERAPY WAS DELIVERED TO THE PATIENT. ELECTRODE LABELING STATES THE IMPORTANCE OF GOOD PLACEMENT ON THE PATIENT AND PROVIDES INSTRUCTION FOR PROPER ELECTRODE APPLICATION TECHNIQUE. ZOLL RECOMMENDS THAT PATIENTS ARE CLEANED AND HAIR IS CLIPPED PRIOR TO APPLYING ELECTRODE PADS TO ASSURE GOOD COUPLING OF ELECTRODE TO SKIN CONTACT. POOR ADHERANCE AND/OR AIR UNDER THE ELECTRODES CAN LEAD TO THE POSSIBILITY OF ARCING/SPARKING. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 70-YEAR-OLD MALE PATIENT, SPARKING WAS SEEN FROM THE ASSOCIATED DEFIB PAD. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559168 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946019259

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death