BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 17249618 · Received July 3, 2023

    Report

    Report Number
    1220908-2023-02477
    Event Type
    Death
    Date Received
    July 3, 2023
    Date of Event
    April 21, 2023
    Report Date
    June 13, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION; INSTEAD, THE CLINICAL DATA FILE WAS PROVIDED. REVIEW OF THE CLINICAL FILE CONFIRMED LOSS OF ECG SIGNAL, COINCIDING WITH PADS OFF MESSAGES. THE CAUSE OF THESE MESSAGES CANNOT BE VERIFIED WITH THE LOG ALONE, HOWEVER THE PADS OFF AND HIGH PATIENT IMPEDANCE IS OFTEN AN INDICATION OF POOR COUPLING. THIS CAN BE CAUSED BY SEVERAL FACTORS OUTSIDE OF A DEVICE OR ACCESSORY MALFUNCTION INCLUDING BUT NOT LIMITED TO POOR CONNECTION FROM THE DEVICE TO THE MFC, POOR CONNECTION FROM THE MFC TO THE PADS, POOR PATIENT PREP, PATIENT SKIN CONDITION, OR POOR CONNECTION FROM PADS TO THE PATIENT. WITHOUT THE PADS, NO FURTHER EVALUATION CAN BE PERFORMED. THIS REPORT HAS BEEN ATTRIBUTED TO POOR COUPLING OF THE ELECTRODE PADS TO THE PATIENT'S SKIN. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 65-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255463 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death